U.S. patent application number 16/173604 was filed with the patent office on 2019-05-02 for systems and methods for protecting the cerebral vasculature.
This patent application is currently assigned to Claret Medical, Inc.. The applicant listed for this patent is Claret Medical, Inc.. Invention is credited to Antony J. Fields, Daniel Wayne Fifer, Whittaker Ian Hamill, Cameron Paul Purcell.
Application Number | 20190125513 16/173604 |
Document ID | / |
Family ID | 64277900 |
Filed Date | 2019-05-02 |
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United States Patent
Application |
20190125513 |
Kind Code |
A1 |
Purcell; Cameron Paul ; et
al. |
May 2, 2019 |
SYSTEMS AND METHODS FOR PROTECTING THE CEREBRAL VASCULATURE
Abstract
Vascular filters and deflectors and methods for filtering bodily
fluids. A blood filtering assembly can capture embolic material
dislodged or generated during an endovascular procedure to inhibit
or prevent the material from entering the cerebral vasculature. A
blood deflecting assembly can deflect embolic material dislodged or
generated during an endovascular procedure to inhibit or prevent
the material from entering the cerebral vasculature.
Inventors: |
Purcell; Cameron Paul;
(Santa Rosa, CA) ; Fields; Antony J.; (Santa Rosa,
CA) ; Hamill; Whittaker Ian; (Petaluma, CA) ;
Fifer; Daniel Wayne; (Windsor, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Claret Medical, Inc. |
Santa Rosa |
CA |
US |
|
|
Assignee: |
Claret Medical, Inc.
Santa Rosa
CA
|
Family ID: |
64277900 |
Appl. No.: |
16/173604 |
Filed: |
October 29, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62577870 |
Oct 27, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/011 20200501;
A61F 2002/016 20130101; A61F 2/013 20130101; A61M 25/0147 20130101;
A61F 2210/0014 20130101; A61F 2230/0093 20130101; A61F 2230/0067
20130101 |
International
Class: |
A61F 2/01 20060101
A61F002/01; A61M 25/01 20060101 A61M025/01 |
Claims
1. A method of inhibiting embolic material from entering cerebral
vasculature, the method comprising: positioning a guidewire through
a right subclavian artery and into a left subclavian artery;
tracking a distal portion of a first protection device over the
guidewire, the distal portion of the first protection device
comprising: an outer sheath; a first self-expanding filter assembly
radially within the outer sheath; and at least one of proximally
retracting the outer sheath and distally advancing the
self-expanding filter assembly to deploy the first self-expanding
filter assembly from the outer sheath in the left subclavian artery
upstream of the left vertebral artery; after deploying the
self-expanding filter assembly, withdrawing the outer sheath from
the right subclavian artery and withdrawing the guidewire into an
innominate artery; tracking a distal portion of a second protection
device over the guidewire, the distal portion of the second
protection device comprising: a proximal sheath; a proximal
self-expanding filter assembly radially within the proximal sheath;
a distal sheath; and a distal self-expanding filter assembly
radially within the distal sheath; at least one of proximally
retracting the proximal sheath and distally advancing the proximal
self-expanding filter assembly to deploy the proximal
self-expanding filter assembly from the proximal sheath in the
innominate artery; steering the distal sheath into a left common
carotid artery; at least one of proximally retracting the distal
sheath and distally advancing the distal self-expanding filter
assembly to deploy the distal self-expanding filter assembly from
the distal sheath in the left common carotid artery; and after
deploying the proximal and distal self-expanding filter assemblies,
withdrawing the proximal and distal sheaths.
2. The method of claim 1, wherein the first protection device and
the second protection device are inserted into a right radial
artery or a right brachial artery through a same incision.
3. The method of claim 1, further comprising performing an
endovascular procedure, the deployed first, proximal, and distal
filter assemblies inhibiting embolic material from entering
cerebral vasculature through the left vertebral artery, a right
common carotid artery, a right vertebral artery and the left common
carotid artery during the endovascular procedure.
4. The method of claim 3, further comprising after performing the
endovascular procedure, withdrawing the first, proximal, and distal
filter assemblies.
5. The method of claim 1, wherein the first protection device
further comprises an inner member radially inward of the outer
sheath.
6. The method of claim 1, further comprising measuring an arterial
pressure using one of the first and second protection devices.
7. The method of claim 1, wherein the first protection device
further comprises a filter wire coupled to a proximal end of the
first self-expanding filter and extending distally therefrom.
8. The method of claim 7, wherein an entirety of a length of the
second protection device is tracked over the filter wire.
9. The method of claim 7, wherein less than an entirety of a length
of the second protection device is tracked over the filter
wire.
10. The method of claim 9, wherein the second protection device
further comprises a rapid exchange port.
11. A method of inhibiting embolic material from entering cerebral
vasculature, the method comprising: positioning a guidewire through
a right subclavian artery and into a left subclavian artery;
tracking a distal portion of a first protection device over the
guidewire, the distal portion of the first protection device
comprising: an outer sheath; an inner member radially inward of the
outer sheath, the inner member comprising a guidewire lumen; and a
first self-expanding filter assembly radially between the outer
sheath and the inner member, the first self-expanding filter
assembly having an opening facing a proximal end of the outer
sheath; at least one of proximally retracting the outer sheath and
distally advancing the self-expanding filter assembly to deploy the
first self-expanding filter assembly from the outer sheath in the
left subclavian artery upstream of the left vertebral artery; after
deploying the self-expanding filter assembly, withdrawing the outer
sheath from the right subclavian artery and withdrawing the
guidewire into an innominate artery; tracking a distal portion of a
second protection device over the guidewire, the distal portion of
the second protection device comprising: a proximal sheath; a
proximal self-expanding filter assembly radially within the
proximal sheath; an articulatable distal sheath; and a distal
self-expanding filter assembly radially within the distal sheath;
at least one of proximally retracting the proximal sheath and
distally advancing the proximal self-expanding filter assembly to
deploy the proximal self-expanding filter assembly from the
proximal sheath in the innominate artery; steering the distal
sheath into a left common carotid artery; at least one of
proximally retracting the distal sheath and distally advancing the
distal self-expanding filter assembly to deploy the distal
self-expanding filter assembly from the distal sheath in the left
common carotid artery; and after deploying the proximal and distal
self-expanding filter assemblies, withdrawing the proximal and
distal sheaths.
12. The method of claim 11, wherein the first protection device and
the second protection device are inserted into a right radial
artery or a right brachial artery through a same incision.
13. The method of claim 11, further comprising performing an
endovascular procedure, the deployed first, proximal, and distal
filter assemblies inhibiting embolic material from entering
cerebral vasculature through the left vertebral artery, a right
common carotid artery, a right vertebral artery and the left common
carotid artery during the endovascular procedure.
14. The method of claim 13, further comprising after performing the
endovascular procedure, withdrawing the first, proximal, and distal
filter assemblies.
15. A method of inhibiting embolic material from entering cerebral
vasculature, the method comprising: positioning a guidewire in a
first artery; tracking a distal portion of a first protection
device over the guidewire, the distal portion of the first
protection device comprising: a proximal sheath; a proximal
self-expanding filter assembly radially within the proximal sheath;
a distal sheath; a distal self-expanding filter assembly radially
within the distal sheath; and an intermediate self-expanding filter
assembly radially within the distal sheath; at least one of
proximally retracting the proximal sheath and distally advancing
the proximal self-expanding filter assembly to deploy the proximal
self-expanding filter assembly from the proximal sheath in the
first artery; steering the distal sheath into a second artery; at
least one of proximally retracting the distal sheath and distally
advancing the distal self-expanding filter assembly to deploy the
distal self-expanding filter assembly from the distal sheath in the
second artery; steering the distal sheath into a third artery; at
least one of proximally retracting the distal sheath and distally
advancing the intermediate self-expanding filter assembly to deploy
the distal self-expanding filter assembly from the distal sheath in
the third artery; and after deploying the proximal, distal, and
intermediate self-expanding filter assemblies, withdrawing the
proximal and distal sheaths.
16. The method of claim 15, wherein the first protection device is
inserted into a right radial artery or a right brachial artery.
17. The method of claim 15, further comprising performing an
endovascular procedure, the deployed proximal, intermediate, and
distal self-expanding filter assemblies inhibiting embolic material
from entering cerebral vasculature through the left vertebral
artery, a right common carotid artery, a right vertebral artery and
the left common carotid artery during the endovascular
procedure.
18. The method of claim 17, further comprising after performing the
endovascular procedure, withdrawing the proximal, intermediate, and
distal filter assemblies.
19. The method of claim 15, wherein the first protection device
further comprises a tether extending between the distal
self-expanding filter assembly and the intermediate self-expanding
filter assembly.
20. The method of claim 19, wherein the tether has a preformed
shape configured to guide the intermediate filter assembly towards
the third artery.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority under 35
U.S.C. .sctn. 119 to U.S. Provisional Application Ser. No.
62/577,870, filed Oct. 27, 2017, the entirety of which is
incorporated herein by reference.
TECHNICAL FIELD
[0002] In general, the present disclosure relates to medical
devices for filtering blood. And, more particularly, in certain
embodiments, to a method and a system of filters and deflectors for
protecting the cerebral arteries from emboli, debris and the like
dislodged during an endovascular or cardiac procedure.
BACKGROUND
[0003] There are four arteries that carry oxygenated blood to the
brain, i.e., the right and left vertebral arteries, and the right
and left common carotid arteries. Various procedures conducted on
the human body, e.g., transcatheter aortic valve replacement
(TAVR), aortic valve valvuloplasty, carotid artery stenting,
closure of the left atrial appendage, mitral valve annuloplasty,
repair or replacement, can cause and/or dislodge materials (whether
native or foreign), these dislodged bodies can travel into one or
more of the cerebral arteries resulting in, inter alia, stroke.
[0004] There exist devices for protecting one or more cerebral
arteries by either collecting (filters) or deflecting (deflectors)
debris. Single filters, such as those used during a carotid artery
stenting are one such device.
[0005] Applicants have previously patented a dual filter embolic
protection system that protects the right vertebral, and right and
left common carotid arteries, see e.g., U.S. Pat. No. 9,492,264,
the entirety of which is incorporated herein. Other attempts at
deflecting debris from entering one or more cerebral arteries using
a deflector placed in the aorta or aortic arch have also been
disclosed. Of the known medical devices, delivery systems, and
methods, each has certain advantages and disadvantages. There is an
ongoing need to provide alternative medical devices and methods as
well as alternative methods for manufacturing and using medical
devices.
SUMMARY
[0006] Certain aspects of the present disclosure address debris,
tissue, etc., that can be dislodged during an endovascular
procedure, this debris can travel toward, into and embolize within
the cerebral vasculature leading to stroke or ischemia in an artery
occluded, partially or totally, by the clot. For example, during a
transcatheter aortic valve replacement (TAVR), stenotic material
around the valve can be dislodged during implantation of the
artificial valve. Moreover, atheroma along and within the aorta and
aortic arch can be dislodged as the TAVR catheter is advanced
toward the diseased aortic valve and subsequently withdrawn after
implantation is completed. In addition, pieces of the catheter
itself can be stripped away during delivery and implantation. These
various forms of vascular debris, whether native or foreign, can
then travel into one or more cerebral arteries, embolize and cause
a stroke, strokes or neurocognitive deficits, for example.
[0007] Certain aspects of the present disclosure are intended to
address these potentially devastating cerebral events by providing
a delivery system comprised of filters and/or deflectors and/or
combinations thereof, to intercept this debris before it can enter
any of the cerebral arteries.
[0008] Certain aspects of the present disclosure, and its various
embodiments, can provide a compound system of filters and/or
deflectors for collecting (and/or deflecting) debris in a manner
such that all four cerebral arteries are protected.
[0009] Vascular filters and deflectors and methods for filtering
bodily fluids are disclosed herein. A blood filtering assembly can
capture embolic material dislodged or generated during an
endovascular procedure to inhibit or prevent the material from
entering the cerebral vasculature. A blood deflecting assembly can
deflect embolic material dislodged or generated during an
endovascular procedure to inhibit or prevent the material from
entering the cerebral vasculature.
[0010] In a first example a method of inhibiting embolic material
from entering cerebral vasculature may comprise positioning a
guidewire through a right subclavian artery and into a left
subclavian artery and tracking a distal portion of a first
protection device over the guidewire. The distal portion of the
first protection device may comprise an outer sheath, a first
self-expanding filter assembly radially within the outer sheath.
The method may further comprise at least one of proximally
retracting the outer sheath and distally advancing the
self-expanding filter assembly to deploy the first self-expanding
filter assembly from the outer sheath in the left subclavian artery
upstream of the left vertebral artery. After deploying the
self-expanding filter assembly, the method may further comprise
withdrawing the outer sheath from the right subclavian artery and
withdrawing the guidewire into an innominate artery and tracking a
distal portion of a second protection device over the guidewire.
The distal portion of the second protection device may comprise a
proximal sheath, a proximal self-expanding filter assembly radially
within the proximal sheath, a distal sheath, and a distal
self-expanding filter assembly radially within the distal sheath
The method may further comprise at least one of proximally
retracting the proximal sheath and distally advancing the proximal
self-expanding filter assembly to deploy the proximal
self-expanding filter assembly from the proximal sheath in the
innominate artery, steering the distal sheath into a left common
carotid artery, at least one of proximally retracting the distal
sheath and distally advancing the distal self-expanding filter
assembly to deploy the distal self-expanding filter assembly from
the distal sheath in the left common carotid artery, and after
deploying the proximal and distal self-expanding filter assemblies,
withdrawing the proximal and distal sheaths.
[0011] Alternatively or additionally to any of the examples above,
in another example, the first protection device and the second
protection device may be inserted into a right radial artery or a
right brachial artery through a same incision.
[0012] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise performing an
endovascular procedure, the deployed first, proximal, and distal
filter assemblies inhibiting embolic material from entering
cerebral vasculature through the left vertebral artery, a right
common carotid artery, a right vertebral artery and the left common
carotid artery during the endovascular procedure.
[0013] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise after
performing the endovascular procedure, withdrawing the first,
proximal, and distal filter assemblies.
[0014] Alternatively or additionally to any of the examples above,
in another example, the first protection device may further
comprise an inner member radially inward of the outer sheath.
[0015] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise measuring an
arterial pressure using one of the first and second protection
devices.
[0016] Alternatively or additionally to any of the examples above,
in another example, the first protection device may further
comprise a filter wire coupled to a proximal end of the first
self-expanding filter and extending distally therefrom.
[0017] Alternatively or additionally to any of the examples above,
in another example, an entirety of a length of the second
protection device may be tracked over the filter wire.
[0018] Alternatively or additionally to any of the examples above,
in another example, less than an entirety of a length of the second
protection device may be tracked over the filter wire.
[0019] Alternatively or additionally to any of the examples above,
in another example, the second protection device may further
comprise a rapid exchange port.
[0020] In another example, a method of inhibiting embolic material
from entering cerebral vasculature may comprise positioning a
guidewire through a right subclavian artery and into a left
subclavian artery and tracking a distal portion of a first
protection device over the guidewire. The distal portion of the
first protection device may comprise an outer sheath, an inner
member radially inward of the outer sheath, the inner member
comprising a guidewire lumen, and a first self-expanding filter
assembly radially between the outer sheath and the inner member,
the first self-expanding filter assembly having an opening facing a
proximal end of the outer sheath. The method may further comprise
at least one of proximally retracting the outer sheath and distally
advancing the self-expanding filter assembly to deploy the first
self-expanding filter assembly from the outer sheath in the left
subclavian artery upstream of the left vertebral artery, after
deploying the self-expanding filter assembly, withdrawing the outer
sheath from the right subclavian artery and withdrawing the
guidewire into an innominate artery, and tracking a distal portion
of a second protection device over the guidewire. The distal
portion of the second protection device may comprise a proximal
sheath, a proximal self-expanding filter assembly radially within
the proximal sheath, an articulatable distal sheath, and a distal
self-expanding filter assembly radially within the distal sheath.
The method may further comprise at least one of proximally
retracting the proximal sheath and distally advancing the proximal
self-expanding filter assembly to deploy the proximal
self-expanding filter assembly from the proximal sheath in the
innominate artery, steering the distal sheath into a left common
carotid artery, at least one of proximally retracting the distal
sheath and distally advancing the distal self-expanding filter
assembly to deploy the distal self-expanding filter assembly from
the distal sheath in the left common carotid artery, and after
deploying the proximal and distal self-expanding filter assemblies,
withdrawing the proximal and distal sheaths.
[0021] Alternatively or additionally to any of the examples above,
in another example, the first protection device and the second
protection device may be inserted into a right radial artery or a
right brachial artery through a same incision.
[0022] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise performing an
endovascular procedure, the deployed first, proximal, and distal
filter assemblies inhibiting embolic material from entering
cerebral vasculature through the left vertebral artery, a right
common carotid artery, a right vertebral artery and the left common
carotid artery during the endovascular procedure.
[0023] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise after
performing the endovascular procedure, withdrawing the first,
proximal, and distal filter assemblies.
[0024] In another example, a method of inhibiting embolic material
from entering cerebral vasculature may comprise positioning a
guidewire in a first artery, tracking a distal portion of a first
protection device over the guidewire. The distal portion of the
first protection device may comprise a proximal sheath, a proximal
self-expanding filter assembly radially within the proximal sheath,
a distal sheath, a distal self-expanding filter assembly radially
within the distal sheath, and an intermediate self-expanding filter
assembly radially within the distal sheath. The method may further
comprise at least one of proximally retracting the proximal sheath
and distally advancing the proximal self-expanding filter assembly
to deploy the proximal self-expanding filter assembly from the
proximal sheath in the first artery, steering the distal sheath
into a second artery, at least one of proximally retracting the
distal sheath and distally advancing the distal self-expanding
filter assembly to deploy the distal self-expanding filter assembly
from the distal sheath in the second artery, steering the distal
sheath into a third artery, at least one of proximally retracting
the distal sheath and distally advancing the intermediate
self-expanding filter assembly to deploy the distal self-expanding
filter assembly from the distal sheath in the third artery, and
after deploying the proximal, distal, and intermediate
self-expanding filter assemblies, withdrawing the proximal and
distal sheaths.
[0025] Alternatively or additionally to any of the examples above,
in another example, the first protection device may be inserted
into a right radial artery or a right brachial artery.
[0026] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise performing an
endovascular procedure, the deployed proximal, intermediate, and
distal self-expanding filter assemblies inhibiting embolic material
from entering cerebral vasculature through the left vertebral
artery, a right common carotid artery, a right vertebral artery and
the left common carotid artery during the endovascular
procedure.
[0027] Alternatively or additionally to any of the examples above,
in another example, the method may further comprise after
performing the endovascular procedure, withdrawing the proximal,
intermediate, and distal filter assemblies.
[0028] Alternatively or additionally to any of the examples above,
in another example, the first protection device may further
comprise a tether extending between the distal self-expanding
filter assembly and the intermediate self-expanding filter
assembly.
[0029] Alternatively or additionally to any of the examples above,
in another example, the tether may have a preformed shape
configured to guide the intermediate filter assembly towards the
third artery.
[0030] In another example, an embolic protection system for
isolating the cerebral vasculature may comprise a first protection
device having a proximal portion configured to remain outside the
body and a distal portion and a second protection device having a
proximal portion configured to remain outside the body and a distal
portion. The distal portion of the first protection device may
comprise an outer sheath and a first self-expanding filter assembly
radially within the outer sheath. The distal portion of the second
protection device may comprise a proximal sheath, a proximal
self-expanding filter assembly radially within the proximal sheath,
a distal sheath, and a distal self-expanding filter assembly
radially within the distal sheath.
[0031] Alternatively or additionally to any of the examples above,
in another example, the first self-expanding filter assembly may
include a proximally facing opening.
[0032] Alternatively or additionally to any of the examples above,
in another example, the proximal self-expanding filter assembly may
include a distally facing opening.
[0033] Alternatively or additionally to any of the examples above,
in another example, the distal self-expanding filter assembly may
include a proximally facing opening.
[0034] Alternatively or additionally to any of the examples above,
in another example, the first protection device may further
comprise a filter wire coupled to a proximal end of the first
self-expanding filter and extending distally therefrom.
[0035] Alternatively or additionally to any of the examples above,
in another example, the second protection device may further
comprise a lumen configured to receive the filter wire of the first
protection device.
[0036] Alternatively or additionally to any of the examples above,
in another example, the lumen may extend over less than an entire
length of the second protection device.
[0037] Alternatively or additionally to any of the examples above,
in another example, the lumen may be in communication with a rapid
exchange port proximally spaced from a distal end of the distal
sheath.
[0038] Alternatively or additionally to any of the examples above,
in another example, the lumen may extend an entirety of a length of
the second protection device.
[0039] Alternatively or additionally to any of the examples above,
in another example, the first protection device may further
comprise an inner member radially inward of the outer sheath.
[0040] Alternatively or additionally to any of the examples above,
in another example, the inner member may comprise a guidewire
lumen.
[0041] Alternatively or additionally to any of the examples above,
in another example, at least one of the first or second protection
devices may be connected to an arterial pressure monitoring
device.
[0042] Alternatively or additionally to any of the examples above,
in another example, the distal sheath may be articulatable.
[0043] Alternatively or additionally to any of the examples above,
in another example, each of the first self-expanding filter, the
proximal self-expanding filter, and the distal self-expanding
filter may be configured to be individually deployed.
[0044] Alternatively or additionally to any of the examples above,
in another example, the embolic protection system may further
comprise a first handle assembly coupled to the proximal portion of
the first embolic protection device and a second handle assembly
coupled to the proximal portion of the second embolic protection
device.
[0045] The above summary of exemplary embodiments is not intended
to describe each disclosed embodiment or every implementation of
the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] The invention may be more completely understood in
consideration of the following detailed description of various
embodiments in connection with the accompanying drawings, in
which:
[0047] FIGS. 1A and 1B illustrate a first embodiment for deploying
three filters to protect the cerebral vascular architecture.
[0048] FIG. 1C illustrates an alternate embodiment of the three
filter system of FIGS. 1A and 1B.
[0049] FIGS. 1D and 1E illustrate an alternate embodiment of the
three filter system of FIG. 1C.
[0050] FIG. 2A illustrates another embodiment of a three filter
system.
[0051] FIGS. 2B and 2C illustrate another alternate embodiment of
the three filter system of FIG. 2A.
[0052] FIGS. 3A-3C illustrate another alternate embodiment of a
three filter system.
[0053] FIGS. 4A-4C illustrate another alternate embodiment of a
three filter system.
[0054] FIG. 5 illustrates an embodiment of a two filter system
deployed to fully protect the cerebral apparatus.
[0055] FIGS. 6A and 6B illustrate embodiments of deploying two
filters and a deflector.
[0056] FIGS. 7A-7D illustrate embodiments where only one oversized
filter is deployed to protect the cerebral vasculature.
[0057] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit aspects
of the invention to the particular embodiments described. On the
contrary, the intention is to cover all modifications, equivalents,
and alternatives falling within the spirit and scope of the
invention.
DETAILED DESCRIPTION
[0058] For the following defined terms, these definitions shall be
applied, unless a different definition is given in the claims or
elsewhere in this specification.
[0059] All numeric values are herein assumed to be modified by the
term "about", whether or not explicitly indicated. The term "about"
generally refers to a range of numbers that one of skill in the art
would consider equivalent to the recited value (i.e., having the
same function or result). In many instances, the term "about" may
be indicative as including numbers that are rounded to the nearest
significant figure.
[0060] The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75,
3, 3.80, 4, and 5).
[0061] Although some suitable dimensions ranges and/or values
pertaining to various components, features and/or specifications
are disclosed, one of skill in the art, incited by the present
disclosure, would understand desired dimensions, ranges and/or
values may deviate from those expressly disclosed.
[0062] As used in this specification and the appended claims, the
singular forms "a", "an", and "the" include plural referents unless
the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.
[0063] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The detailed description and the
drawings, which are not necessarily to scale, depict illustrative
embodiments and are not intended to limit the scope of the
invention. The illustrative embodiments depicted are intended only
as exemplary. Selected features of any illustrative embodiment may
be incorporated into an additional embodiment unless clearly stated
to the contrary.
[0064] The currently marketed Sentinel system made by Claret
Medical and embodiments of which are described in U.S. Pat. No.
9,492,264 mentioned above has two filters, a first which protects
the right brachiocephalic artery, from which the right vertebral
and right common carotid arteries typically originate, and a second
filter in the left common carotid artery. In a typical patient, the
left vertebral which provides approximately seven percent of the
perfusion to the brain is left unprotected.
[0065] One disclosed solution to protecting the left vertebral is
the use of a second device intended to be placed in the left arm,
e.g. through the left radial artery, with a filter placed in the
left subclavian from which the left vertebral typically originates.
Embodiments of such a solution can be found in U.S. Pat. No.
9,566,144, the entirety of which is hereby incorporated by
reference herein and included as part of this Specification in an
Appendix (labeled Appendix B) filed with this patent
application.
[0066] While procedurally compatible, it may be preferred to
achieve protection of all cerebral vessels from one access point.
Deflector concepts which reside in the arch have been previously
disclosed, and these devices can have a single access point of
either the right arm, left arm or femoral artery. While deflector
concepts which reside in the arch are technically feasible, they
may result in substantial interference with the therapy (e.g. TAVR)
or procedure, or may not be sufficiently compatible with the
breadth of sizes and configurations of aortic arches to provide
complete protection of the brain.
[0067] The present application discloses several single-access
multi-vessel embodiments that can provide full cerebral protection
with minimal arch interference.
[0068] The disclosure generally relates to devices and methods for
filtering fluids and/or deflecting debris contained within fluids,
including body fluids such as blood. A filtering or deflecting
device can be positioned in an artery before and/or during an
endovascular procedure (e.g., transcatheter aortic valve
implantation (TAVI) or replacement (TAVR), transcatheter mitral
valve implantation (TAMI) or replacement (TAMR), surgical aortic
valve replacement (SAVR), other surgical valve repair,
implantation, or replacement, cardiac ablation (e.g., ablation of
the pulmonary vein to treat atrial fibrillation) using a variety of
energy modalities (e.g., radio frequency (RF), energy, cryo,
microwave, ultrasound), cardiac bypass surgery (e.g., open-heart,
percutaneous), transthoracic graft placement around the aortic
arch, valvuloplasty, etc.) to inhibit or prevent embolic material
such as debris, emboli, thrombi, etc. resulting from entering the
cerebral vasculature.
[0069] The devices may be used to trap and/or deflect particles in
other blood vessels within a subject, and they can also be used
outside of the vasculature. The devices described herein are
generally adapted to be delivered percutaneously to a target
location within a subject, but can be delivered in any suitable way
and need not be limited to minimally-invasive procedures.
[0070] FIG. 1A is a schematic view of an aortic arch 10 including a
first protection device 30. The aortic arch 10 is upstream of the
left and right coronary arteries (not explicitly shown). The aortic
arch 10 typically includes three great branch arteries: the
brachiocephalic artery or innominate artery 12, the left common
carotid artery 14, and the left subclavian artery 16. The
innominate artery 12 branches to the right carotid artery 18, then
the right vertebral artery 20, and thereafter is the right
subclavian artery 22. The right subclavian artery 22 supplies blood
to, and may be directly accessed from (termed right radial access),
the right arm. The left subclavian artery 16 branches to the left
vertebral artery 24, usually in the shoulder area. The left
subclavian artery 16 supplies blood to, and may be directly
accessed from (termed left radial axis), the left arm. Four of the
arteries illustrated in FIG. 1A supply blood to the cerebral
vasculature: (1) the left carotid artery 14 (about 40% of cerebral
blood supply); (2) the right carotid artery 18 (about 40% of
cerebral blood supply); (3) the right vertebral artery 20 (about
10% of cerebral blood supply); and (4) the left vertebral artery 24
(about 10% of cerebral blood supply).
[0071] It may be desirable to filter blood flow to all four
arteries 14, 18, 20, 24 supplying blood to the brain and/or deflect
particulates from entering the arteries 14, 18, 20, 24 supplying
the brain. It may also be desirable to limit the number of incision
sites or cuts required to deploy the system(s). FIG. 1A illustrates
a first step in deploying a multi-filter system using a right
radial access incision. The first filter 32 may be deployed in the
left subclavian artery 16 upstream of the left vertebral artery
24.
[0072] The protection device, or filter system, 30 comprises a
proximal portion 34 and a distal portion 36. The proximal portion
34 is configured to be held and manipulated by a user such as a
surgeon. The distal portion 36 is configured to be positioned at a
target location such as the left subclavian artery 16 or the left
vertebral artery 24. When the distal portion 36 is configured to be
positioned at the left subclavian artery 16, the location may be
upstream of the left vertebral artery 24 such that the blood is
filter prior to entering the left vertebral artery 24.
[0073] The proximal portion 34 may include a handle 38, a control
40 such as a slider, an outer sheath 42, a port 44, optionally an
inner member translation control 46 such as a knob, and optionally
a hemostasis valve control 48 such as a knob. The proximal portion
34 may also comprises an inner member 50 radially inward of the
outer sheath 42. While not explicitly shown, the proximal portion
34 may also comprise a filter wire 52b radially inward of the outer
sheath 42 (and sometimes radially outward of the inner member 50).
Some illustrative filter wires are described in commonly assigned
U.S. Pat. No. 9,566,144, the entirety of which is hereby
incorporated by reference. The filter wire 52b may be coupled to
the filter assembly 32 in the distal portion 36. The outer sheath
42 may have a diameter between about 4 French (Fr) (approximately
1.33 millimeters (mm)) and about 6 Fr (approximately 2 mm) (e.g.,
about 5 Fr (approximately 1.67 mm)).
[0074] The protection device 30 may further include a guidewire 56
disposed within a lumen of the inner member 50. The outer sheath 42
may comprise an atraumatic distal tip. Other features of the
protection device 30 and other protection devices described herein
may be flexible and/or atraumatic. The outer sheath 42 may comprise
a curvature, for example based on an intended placement location
(e.g., the left subclavian artery and/or the left vertebral
artery).
[0075] The slider 40 can be used to translate the outer sheath 42
and/or a filter assembly 32 (e.g., coupled to a filter wire 52b).
For example, the slider 40 may proximally retract the outer sheath
42, the slider 40 may distally advance the filter assembly 32 out
of the outer sheath 42, or the slider 40 may proximally retract the
outer sheath 42 and distally advance the filter assembly 32 (e.g.,
simultaneously or serially), which can allow the filter assembly 32
to radially expand. The slider 40 may also be configured to have an
opposite translation effect, which can allow the filter assembly 32
to be radially collapsed (e.g., due to compression by the outer
sheath 42) as the filter assembly 32 is drawn into the outer sheath
42. Other deployment systems are also possible, for example
comprising gears or other features such as helical tracks (e.g.,
configured to compensate for any differential lengthening due to
foreshortening of the filter assembly 32, configured to convert
rotational motion into longitudinal motion), a mechanical element,
a pneumatic element, a hydraulic element, etc. for opening and/or
closing the filter assembly 32.
[0076] The port 44 is in fluid communication with the inner member
50 (e.g., via a Y-shaped connector in the handle 38). The port 44
can be used to flush the device (e.g., with saline) before, during,
and/or after use, for example to remove air. The port 44 can
additionally, or alternatively, be used to monitor blood pressure
at the target location, for example by connecting an arterial
pressure monitoring device in fluid communication with a lumen of
the outer sheath 42. The port 44 can be also or alternatively be
used to inject contrast agent, dye, thrombolytic agents such as
tissue plasminogen activator (t-PA), etc. The slider 40 may be
independent of the inner member 50 such that the inner member 50 is
longitudinally movable independent of the filter assembly 32 and
the outer sheath 42. The inner member translation control 46 can be
used to longitudinally translate the inner member 50, for example
before, after, and/or during deployment of the filter assembly 32.
The inner member translation control 46 may comprise a slider in
the housing 38 (e.g., separate from the slider 40).
[0077] The rotatable hemostasis valve control 48 can be used to
reduce or minimize fluid loss through the protection device 30
during use. For example, a proximal portion and/or intermediate
region of the protection device may be positioned in the right
subclavian artery 22 and the direction of blood flow with respect
to the device 30 will be distal to proximal, so blood may be
otherwise inclined to follow the pressure drop out of the device
30. The hemostasis valve control 48 is illustrated as being
rotatable, but other arrangements are also possible (e.g.,
longitudinally displaceable). The hemostasis valve control 48 may
be configured to fix relative positions of the outer sheath 42 and
the filter assembly 32, for example as described with respect to
the hemostasis valve in U.S. Pat. No. 8,876,796. The hemostasis
valve 48 may comprise, for example, an elastomeric seal and HV
nut.
[0078] The distal portion 36 may include the outer sheath 42, a
filter assembly 32 radially inward of the outer sheath 42 in a
delivery configuration (not explicitly shown), and optionally the
inner member 50. The filter assembly 32 may be radially between the
outer sheath 42 and the inner member 50 (e.g., radially inward of
the outer sheath 42 and the inner member 50 radially inward of the
filter assembly 32) in a delivery state or shape or position.
[0079] The filter assembly 32 may include a support element or
frame 31 and a filter element 33. The frame 31 may generally
provide expansion support to the filter element 33 in the expanded
state. In the expanded state, the filter element 33 is configured
to filter fluid (e.g., blood) flowing through the filter element 33
and to inhibit or prevent particles (e.g., embolic material) from
flowing through the filter element 33 by capturing the particles in
the filter element 33.
[0080] The frame 31 is configured to engage or appose the inner
walls of a lumen (e.g., blood vessel) in which the frame assembly
32 is expanded. The frame 31 may comprise or be constructed of, for
example, nickel titanium (e.g., nitinol), nickel titanium niobium,
chromium cobalt (e.g., MP35N, 35NLT), copper aluminum nickel, iron
manganese silicon, silver cadmium, gold cadmium, copper tin, copper
zinc, copper zinc silicon, copper zinc aluminum, copper zinc tin,
iron platinum, manganese copper, platinum alloys, cobalt nickel
aluminum, cobalt nickel gallium, nickel iron gallium, titanium
palladium, nickel manganese gallium, stainless steel, combinations
thereof, and the like. The frame 31 may comprise a wire (e.g.,
having a round (e.g., circular, elliptical) or polygonal (e.g.,
square, rectangular) cross-section). For example, in some
embodiments, the frame 31 comprises a straight piece of nitinol
wire shape set into a circular or oblong hoop or hoop with one or
two straight legs running longitudinally along or at an angle to a
longitudinal axis of the frame assembly 32. At least one of the
straight legs may be coupled to a filter wire 52a or a strut 52a.
The straight legs may be on a long side of the filter assembly 32
and/or on a short side of the filter assembly 32. The frame 31 may
form a shape of an opening 35 of the filter assembly 32. The
opening 35 may be circular, elliptical, or any shape that can
appropriately appose sidewalls of a vessel such as the left
subclavian artery or the left vertebral artery. The filter assembly
32 may have a generally proximally-facing opening 35. In other
embodiments, the opening 35 may be distally facing. The orientation
of the opening 35 may vary depending on where the access incision
is located.
[0081] The frame 31 may include a radiopaque marker such as a small
coil wrapped around or coupled to the hoop to aid in visualization
under fluoroscopy. In some embodiments, the frame may not comprise
a shape other than a hoop, for example a spiral. In some
embodiments, the filter assembly 32 may not include or be
substantially free of a frame.
[0082] In some embodiments, the frame 31 and the filter element 33
form an oblique truncated cone having a non-uniform or unequal
length around and along the length of the filter assembly 32. In
such a configuration, along the lines of a windsock, the filter
assembly 32 has a larger opening 35 (upstream) diameter and a
reduced ending (downstream) diameter.
[0083] The filter element 33 may include pores configured to allow
blood to flow through the filter element 33, but that are small
enough to inhibit prevent particles such as embolic material from
passing through the filter element 33. The filter element 33 may
comprise a filter membrane such as a polymer (e.g., polyurethane,
polytetrafluoroethylene (PTFE)) film mounted to the frame 32. The
filter element may have a thickness between about 0.0001 inches and
about 0.03 inches (e.g., no more than about 0.0001 inches, about
0.001 inches, about 0.005 inches, about 0.01 inches, about 0.015
inches, about 0.02 inches, about 0.025 inches, about 0.03 inches,
ranges between such values, etc.).
[0084] The film may comprise a plurality of pores or holes or
apertures extending through the film. The film may be formed by
weaving or braiding filaments or membranes and the pores may be
spaces between the filaments or membranes. The filaments or
membranes may comprise the same material or may include other
materials (e.g., polymers, non-polymer materials such as metal,
alloys such as nitinol, stainless steel, etc.). The pores of the
filter element 33 are configured to allow fluid (e.g., blood) to
pass through the filter element 33 and to resist the passage of
embolic material that is carried by the fluid. The pores can be
circular, elliptical, square, triangular, or other geometric
shapes. Certain shapes such as an equilateral triangular, squares,
and slots may provide geometric advantage, for example restricting
a part larger than an inscribed circle but providing an area for
fluid flow nearly twice as large, making the shape more efficient
in filtration verses fluid volume. The pores may be laser drilled
into or through the filter element 33, although other methods are
also possible (e.g., piercing with microneedles, loose braiding or
weaving). The pores may have a lateral dimension (e.g., diameter)
between about 10 micron (.mu.m) and about 1 mm (e.g., no more than
about 10 .mu.m, about 50 .mu.m, about 100 .mu.m, about 150 .mu.m,
about 200 .mu.m, about 250 .mu.m, about 300 .mu.m, about 400 .mu.m,
about 500 .mu.m, about 750 .mu.m, about 1 mm, ranges between such
values, etc.). Other pore sizes are also possible, for example
depending on the desired minimum size of material to be
captured.
[0085] The material of the filter element 33 may comprise a smooth
and/or textured surface that is folded or contracted into the
delivery state by tension or compression into a lumen. A
reinforcement fabric may be added to or embedded in the filter
element 33 to accommodate stresses placed on the filter element 33
during compression. A reinforcement fabric may reduce the
stretching that may occur during deployment and/or retraction of
the filter assembly 32. The embedded fabric may promote a folding
of the filter to facilitate capture of embolic debris and enable
recapture of an elastomeric membrane. The reinforcement material
could comprise, for example, a polymer and/or metal weave to add
localized strength. The reinforcement material could be imbedded
into the filter element 33 to reduce thickness. For example,
imbedded reinforcement material could comprise a polyester weave
mounted to a portion of the filter element 33 near the longitudinal
elements of the frame 31 where tensile forces act upon the frame 31
and filter element 33 during deployment and retraction of the
filter assembly 32 from the outer sheath 42.
[0086] In some cases, the filter assembly 32 may include a
self-expanding filter assembly (e.g., comprising a superelastic
material with stress-induced martensite due to confinement in the
outer sheath 42). The filter assembly 32 may comprise a
shape-memory material configured to self-expand upon a temperature
change (e.g., heating to body temperature). The filter assembly 32
may comprise a shape-memory or superelastic frame (e.g., comprising
a distal end hoop comprising nitinol) and a microporous material
(e.g., comprising a polymer including laser-drilled holes) coupled
to the frame, for example similar to the filter assemblies
described in U.S. Pat. No. 8,876,796.
[0087] The filter assembly 32 may be coupled (e.g., crimped,
welded, soldered, etc.) to a distal end of a deployment wire or
filter wire 52b via a strut or wire 52a. When both or all of the
filter wire 52a and the strut 52a are provided, the filter wire 52b
and the strut 52a may be coupled within the outer sheath 42
proximal to the filter assembly 30 using a crimp mechanism. In
other embodiments, the filter wire 52b and the strut 52a may be a
single unitary structure. The filter wire 52b and/or strut 52a can
comprise a rectangular ribbon, a round (e.g., circular, elliptical)
filament, a portion of a hypotube, a braided structure (e.g., as
described herein), combinations thereof, and the like. The filter
wire 52b can be coupled to the handle 38 and/or the slider 40 to
provide differential longitudinal movement versus the outer sheath
42, as shown by the arrows 54, which can sheathe and unsheathe the
filter assembly 32 from the outer sheath 42.
[0088] The filter assembly 32 in an expanded, unconstrained state
has a maximum diameter or effective diameter (e.g., if the mouth is
in the shape of an ellipse) d. The diameter d can be between about
1 mm and about 15 mm (e.g., at least about 1 mm, about 2 mm, about
3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm,
about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm,
about 14 mm, about 15 mm, ranges between such values, etc.). In
some embodiments (e.g., when the filter assembly is configured to
be positioned in the left subclavian artery), the diameter d is
between about 7 mm and about 12 mm (e.g., about 7 mm, about 8 mm,
about 9 mm, about 10 mm, about 11 mm, about 12 mm, ranges between
such values, etc.). In some embodiments (e.g., when the filter
assembly is configured to be positioned in the left vertebral
artery), the diameter d is between about 2 mm and about 4.5 mm
(e.g., about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4
mm, about 4.5 mm, ranges between such values, etc.). Other
diameters d or other types of lateral dimensions are also possible.
Different diameters d can allow treatment of a selection of
subjects having different vessel sizes.
[0089] The filter assembly 32 has a maximum length 1. The length 1
can be between about 7 mm and about 50 mm (e.g., at least about 7
mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm,
about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm,
about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm,
about 23 mm, about 24 mm, about 25 mm, about 30 mm, about 35 mm,
about 40 mm, about 45 mm, about 50 mm, ranges between such values,
etc.). Other lengths 1 are also possible, for example based on the
diameter or effective diameter d. For example, the length 1 of the
filter assembly 32 may increase as the diameter d increases, and
the length 1 of the filter assembly 32 may decrease as the diameter
d decreases. A distance from an apex of the mouth of the filter
assembly 32 to an elbow in the frame may be about 35 mm. Different
lengths 1 can allow treatment of a selection of subjects having
different vessel sizes.
[0090] The inner member 50 may be optional, but can provide
additional uses and/or advantages in combination with the filter
assembly 32. For example, the inner member 50 may comprise a
guidewire lumen (not explicitly shown), allowing the device 30 to
be tracked over a guidewire 56 without contacting the filter
assembly 32. For another example, a lumen of the inner member 50
may be fluidly coupled to the flush port 44, which can allow
flushing of fluid through the inner member 50, for example to
remove air. For yet another example, a lumen of the inner member 50
may be connected to an arterial pressure monitoring device,
allowing measurement of pressure proximate to the location of the
filter assembly 32.
[0091] The distal portion 36 may include fluoroscopic markers one
or more 58a, 58b to aid a user in positioning the device 30,
deploying the filter assembly 32, utilizing the inner member 50,
etc. A fluoroscopic marker 58b may be positioned is proximate to a
distal end of the outer sheath 42. Another fluoroscopic marker (not
explicitly shown) may be positioned proximate to a proximal end of
the filter assembly 32. In some cases, another fluoroscopic marker
58b maybe proximate to a distal end of the filter assembly 32.
Another fluoroscopic marker (not explicitly shown) may be proximate
to a distal end of the inner member 50. The fluoroscopic markers
may comprise a radiopaque material (e.g., iridium, platinum,
tantalum, gold, palladium, tungsten, tin, silver, titanium, nickel,
zirconium, rhenium, bismuth, molybdenum, combinations thereof, and
the like). More or fewer fluoroscopic markers are also
possible.
[0092] The protection device 30 is illustrated as comprising a
guidewire 56 therethrough, although the guidewire 56 may be
characterized as being separate from the protection device 30, for
example independently sold, packaged, and/or directed. The
guidewire 56 may extend through a lumen of the outer sheath 42 or
the inner member 50. The lumen of the outer sheath 42 or the inner
member 50 (if so provided) may be configured to receive a guidewire
56 having a diameter between about 0.014 inches (0.356 mm) and
about 0.025 inches (0.635 mm). The guidewire 56 may extend through
a lumen of the filter assembly 32. For example, the protection
device 30 may be tracked over the guidewire 56 to position the
protection device 30 at a desired location.
[0093] The filter assembly 32 may be positioned, for example, in
the left subclavian artery 16, to protect the cerebral vasculature
(e.g., the left vertebral artery 24) from embolic debris during an
endovascular procedure such as TAVI. While the procedure described
positioning the first filter assembly 32 in the left subclavian
artery, the method is not limited to positioning the first filter
assembly 32 within the left subclavian artery, the first filter
assembly 32 may be positioned within other arteriers (or other
lumens), as desired. The filter assembly 32 may be positioned in
the left subclavian artery 16 upstream of the left vertebral artery
24. The user may choose a protection device 30 comprising a
proximal-facing filter assembly 32 having a diameter appropriate
for the artery (or other lumen) in which it is to be deployed, for
example, but not limited to, between about 7 mm and about 12 mm for
the left subclavian artery 16. The protection device 30 may be
packaged in a sterile coiled packaging. The protection device 30
may comprise an outer sheath 42 having a diameter of about 5 Fr
(approximately 1.67 mm). The outer sheath 42 may include a
curvature, for example complementing the size and orientation of
the filter assembly 32. The outer sheath 42 may be steerable (e.g.,
a pull wire-controlled sheath).
[0094] Lumens of the protection device 30, for example a lumen of
the outer sheath 42 and a lumen of the inner member 50, may be
flushed (e.g., using saline) once or several times before, during,
and/or after the procedure. The filter assembly 32 of the
protection device 30 may be flushed and/or submerged (e.g., in a
bowl of saline). Flushing and/or submerging of the filter assembly
32 may be with the filter assembly 32 in the outer sheath 42 (e.g.,
in the compressed state) and/or with the filter assembly 32 out of
the outer sheath 42 (e.g., in the deployed state). If the filter
assembly 32 is flushed and/or submerged in the deployed state, the
filter assembly 32 may be compressed into the outer sheath 42
before use.
[0095] An artery in the right arm is accessed, for example using a
5 Fr introducer. The guidewire 56 (e.g., having a diameter between
about 0.014 inches and about 0.25 inches) is steered, into or
towards the right subclavian artery 22, then into the innominate
artery 12, then into the aortic arch 10, and finally into the left
subclavian artery 16. In some cases, a distal end of the guidewire
56 may be curved (e.g., a pigtail curve) to facilitate navigation
from the right subclavian artery 22 to the left subclavian artery
16. A proximal end of the guidewire may be inserted into a distal
end of the protection device 30, for example into a distal end of
an inner member 50. During navigation through the vasculature, the
filter assembly 32 may be disposed within a lumen of the outer
sheath and held in a collapsed position therein until the filter
assembly 32 advanced distally from the outer sheath 42 and/or the
outer sheath 42 is proximally retracted relative to the filter
assembly 32. The protection device 30 may be tracked over the
guidewire until the distal end of the protection device 30 extends
beyond a distal end of the introducer. In some implementations, the
guidewire and the protection device 30 may be tracked together,
with the guidewire leading the device 30 (e.g., advance the
guidewire a distance, then advance the device 30 over the guidewire
approximately the same distance). In some cases, where the
guidewire and the inner member 50 may both be floppy or lack
rigidity, they may be introduced inside the outer sheath 42 and
then advanced ahead of the device 30 in the vasculature. The
guidewire may be advanced at least about 6 centimeters (cm) distal
to the distal end of the protection device 30.
[0096] The protection device 30 may be tracked or distally advanced
over the guidewire until the proximal end of the protection device
30 (e.g., the opening 35) is at a desired location such as
proximate to the left subclavian artery ostium 17, just above the
aortic arch 10. Tracking of the protection device 30 may be
performed under fluoroscopy, for example using radiopaque markers
(e.g., at a distal end of the outer sheath 42 and/or the inner
member 50) and/or radiopaque fluid or contrast media. Radiopaque
fluid may be provided through the inner member 50 and/or the outer
sheath 42. The protection device 30 may be positioned so that the
filter assembly 32 is upstream of the left vertebral artery 24 or
proximate to the ostium 17 so that the filter assembly 32 can
inhibit or prevent embolic material from entering the cerebral
vasculature through the left vertebral artery 24. Using terminology
of the procedure rather than blood flow, the protection device 30
is preferably positioned so that the filter assembly 32 is proximal
to the point in the left subclavian artery 16 where the left
vertebral artery 24 branches off. However, it is contemplated that
positioning may be based on available anatomy.
[0097] Once the protection device 30 is in position, the filter
assembly 32 may be deployed from the outer sheath 42. For example,
the outer sheath 42 may be proximally retracted and/or the filter
assembly 32 may be distally advanced. Radiopaque markers, for
example on the filter assembly 32 can help determine when the
filter assembly 32 achieves a deployed state. Differential
longitudinal movement of the filter assembly 32 and the outer
sheath 42 can cease upon full or appropriate deployment of the
filter assembly 32. Apposition of the filter assembly 32 with
sidewalls of the left subclavian artery 16 can be verified, for
example using radiopaque fluid or contrast media. Radiopaque fluid
may be provided through the inner member 50. If the radiopaque
fluid is able to flow between the frame of the filter assembly 32
and the sidewalls of the left subclavian artery 16, then the filter
assembly 32 may be improperly positioned (e.g., indicative of
inadequate deployment, inadequate sizing, calcium, etc.). The
filter assembly 32 may be retracted back into the outer sheath 42
and redeployed, or a different protection device may be used.
[0098] After positioning of the protection device 30, the outer
sheath 42 and the inner member 50 may be withdrawn while the filter
wire 52b and/or strut 52a are left in place. It is contemplated
that the filter wire 52b and/or strut 52a may function as a
guidewire to direct the outer sheath 42 back to the filter assembly
32 when removal of the filter assembly 32 is desired.
Alternatively, or additionally, the guidewire 56 may be left in
place during the endovascular procedure (e.g., TAVI, TAVR, TAMI,
TAMR, SAVR, other surgical valve repair, implantation, or
replacement, cardiac ablation, cardiac bypass surgery, etc.). In
some embodiments, the inner member 50 may be retracted to a
position suitable for monitoring or sensing blood pressure. For
example, a blood pressure monitoring device can be connected in
fluid communication to the inner member 50 (e.g., using a luer
fitting). In embodiments in which the protection device lacks an
inner member, blood pressure may be monitored or sensed by
connecting a blood pressure monitoring device to the outer sheath
42.
[0099] The protection devices described herein may be used alone or
in combination with other protection devices. For example, a second
protection device as described herein may be advanced via the right
subclavian artery and positioned in both the innominate artery 12
and the left common carotid artery 14, providing protection to the
right carotid artery, the right vertebral artery, and the left
carotid artery 14. For another example, an aortic arch filter or
deflector such as the Embrella Embolic Deflector System, the
TriGuard embolic protection system, or the like may be placed
across the great branch artery ostia and/or apposing sidewalls of
the aortic arch upstream of at least one of the great branch artery
ostia. For another example, the filter systems and methods
described in U.S. Pat. No. 8,876,796 can be used in combination
with the protection devices described herein to further protect the
cerebral vasculature during an endovascular procedure.
[0100] For example, after the first filter assembly 32 has been
positioned, a second protection device, or filter system, 60 may be
deployed in the innominate artery 12 and the left common carotid
artery 14, as shown in FIG. 1B. FIG. 1B illustrates an example
distal portion of a second protection device 60 having two filter
assemblies 62, 64 in a deployed state. Illustrative protection
devices including two filter assemblies are described in commonly
assigned U.S. Pat. No. 9,492,264, the entirety of which is hereby
incorporated by reference.
[0101] The second protection device 60 may include a distal end
region 66 including at least the filter assembles 62, 64 and a
proximal end region (not explicitly shown) coupled to a handle (not
explicitly shown) configured to remain outside the body. In some
cases, the handle of the second protection device 60 may be similar
in form and function to the handle 38 described herein. The distal
end region 66 may include a proximal sheath 68, a proximal shaft 70
coupled to an expandable proximal filter assembly 64, a distal
shaft 72 coupled to a distal articulatable sheath 74, a distal
filter 62, and guiding member 76.
[0102] The proximal shaft 70 is co-axial with proximal sheath 68,
and a proximal region 78 of proximal filter assembly 64 is secured
to proximal shaft 70. In its collapsed configuration (not
explicitly shown), the proximal filter assembly 64 may be disposed
within proximal sheath 68 and is disposed distally relative to
proximal shaft 70. The proximal sheath 68 may be axially (distally
and proximally) movable relative to proximal shaft 70 and the
proximal filter assembly 64. The system 60 may also include a
distal sheath 74 secured to a distal region of distal shaft. The
distal shaft 72 may be co-axial with the proximal shaft 70 and the
proximal sheath 68. The distal sheath 74 and distal shaft 72 may be
secured to one another axially movable relative to proximal sheath
68, the proximal shaft 70 and the proximal filter assembly 64. The
system 60 may also include a distal filter assembly 62 carried by
the guiding member 76. While not explicitly shown, the distal
filter assembly 62 may be maintained in a collapsed configuration
within the distal sheath 74. The guiding member 76 may be coaxial
with distal sheath 74 and distal shaft 72 as well as proximal
sheath 68 and proximal shaft 70. The guiding member 76 may be
axially movable relative to distal sheath 74 and distal shaft 72 as
well as proximal sheath 68 and proximal shaft 70. The proximal
sheath 68, the distal sheath 74, and the guiding member 76 may each
be adapted to be independently moved axially relative to one other.
That is, the proximal sheath 68, the distal sheath 74, and the
guiding member 76 are adapted for independent axial translation
relative to each of the other two components. It is contemplated
that the handle may include control elements (such as, but not
limited to, slides, switches, buttons, dials, etc.) configured to
individually actuate the proximal sheath 68, the distal sheath 74,
and the guiding member 76.
[0103] The proximal filter assembly 64 may include a support
element or frame 65 and filter element 67. Similarly, the distal
filter assembly 62 includes support element 61 and filter element
63. The frames 61, 65 may be similar in form and function to the
frame 31 described herein. Similarly, the filter elements 63, 67
may be similar in form and function to the filter element 33
described herein. The support elements 61, 65 generally provide
expansion support to the filter elements 63, 67 in their respective
expanded configurations, while the filter elements 63, 67 are
adapted to filter fluid, such as blood, and trap particles flowing
therethrough. The expansion supports 61, 65 are adapted to engage
the wall of the lumen in which they are expanded. The filter
elements 63, 67 have pores therein that are sized to allow the
blood to flow therethrough, but are small enough to prevent
unwanted foreign particles from passing therethrough. The foreign
particles are therefore trapped by and within the filter elements
63, 67.
[0104] As shown in FIG. 1B, the proximal filter 64 has a generally
distally-facing opening 80, and the distal filter 62 has a
generally proximally-facing opening 82 relative to the device 60.
The filter assemblies 62, 64 can be thought of as facing opposite
directions. As described in more detail below, the distal sheath 74
may be adapted to be steered, or bent, relative to the proximal
sheath 68 and the proximal filter 64. As the distal sheath 74 is
steered, the relative directions in which the openings face will be
adjusted. Regardless of the degree to which the distal sheath 74 is
steered, the filter assemblies 62, 64 are still considered to
having openings facing opposite directions. For example, the distal
sheath 74 could be steered to have an approximately 720 degree
bend, in which case the filter assemblies 62, 64 would have
openings 82, 80 facing in substantially the same direction, as
shown in FIG. 1B. The directions of the filter openings 80, 82 are
therefore described if the system were to assume a substantially
straightened configuration (not explicitly shown). The proximal
filter element 67 may taper down in the proximal direction from
support element 65, while the distal filter element 63 may taper
down in the distal direction from support element 61. A fluid, such
as blood, flows through the opening and passes through the pores in
the filter elements 63, 67, while the filter elements 63, 67 are
adapted to trap foreign particles therein and prevent their passage
to a location downstream of the filter assemblies.
[0105] The filters 62, 64 may be secured to separate system
components. For example, the proximal filter assembly 64 is secured
to the proximal shaft 70, while the distal filter assembly 62 is
secured to guiding member 76. In FIG. 1B, the filters 62, 64 are
secured to independently actuatable components. This may allow the
filters 62, 64 to be independently positioned and controlled.
Additionally, the filters 62, 64 may be collapsed within two
different tubular members in their collapsed configurations. For
example, the proximal filter assembly 64 is collapsed within
proximal sheath 68, while the distal filter assembly 62 is
collapsed within distal sheath 74. In the system's delivery
configuration, the filter assemblies 62, 64 are axially-spaced from
one another. For example, in FIG. 1B, the distal filter assembly 62
is distally-spaced relative to proximal filter assembly 64.
However, in an alternative embodiment, the filter assemblies 62, 64
may be positioned such that a first filter is located within a
second filter.
[0106] In some embodiments, the distal sheath 74 and the proximal
sheath 68 have substantially the same outer diameter. When the
filter assemblies 62, 64 are collapsed within the sheaths, the
sheath portion of the system 60 therefore has a substantially
constant outer diameter, which can ease the delivery of the system
60 through the patient's body and increase the safety of the
delivery. The distal and proximal sheaths 74 and 68 may have
substantially the same outer diameter, both of which have larger
outer diameters than the proximal shaft 70. The proximal shaft 70
may have a larger outer diameter than the distal shaft 72, wherein
the distal shaft 72 is disposed within the proximal shaft 70. The
guiding member 76 may have a smaller diameter than the distal shaft
72. In some embodiments the proximal and distal sheaths 68, 74 have
an outer diameter between 3 French (F) and 70 F. In certain
embodiments, the outer diameter is between 4 F and 8 F. In still
other embodiments, the outer diameter is between 4 F and 6 F. In
some embodiments, the sheaths 68, 74 have different outer
diameters. For example, the proximal sheath 68 can have a size of 6
F, while the distal sheath 74 has a size of 5 F. In an alternate
embodiment the proximal sheath 68 is 5 F and the distal sheath 74
is 4 F. These are just examples and are not intended to limit the
sheaths 68, 74 to a particular size. A distal sheath 74 with a
smaller outer diameter than the proximal sheath 68 reduces the
delivery profile of the system 60 and can ease delivery. In some
methods of use, the filter system 60 is advanced into the subject
through an incision made in the subject's right radial artery, or
alternatively the right brachial artery. In a variety of medical
procedures a medical instrument is advanced through a subject's
femoral artery, which is larger than the right radial artery. A
delivery catheter used in femoral artery access procedures has a
larger outer diameter than would be allowed in a filter system
advanced through a radial artery. Additionally, in some uses the
filter system is advanced from the right radial artery into the
aorta via the brachiocephalic trunk. The radial artery has the
smallest diameter of the vessels through which the system is
advanced. The radial artery therefore limits the size of the system
that can be advanced into the subject when the radial artery is the
access point. The outer diameters of the systems described herein,
when advanced into the subject via a radial artery, are therefore
smaller than the outer diameters of the guiding catheters (or
sheaths) typically used when access is gained via a femoral
artery.
[0107] The system 60 may be delivered to the left carotid artery 14
and the innominate artery 12 in a delivery configuration. The
system's delivery configuration generally refers to the
configuration when both filter assemblies 62, 64 are in collapsed
configurations within the system. The distal articulating sheath 74
may be independently movable with 3 degrees of freedom relative to
the proximal sheath 68 and proximal filter 64. In some embodiments,
the proximal sheath 68 and the distal sheath 74 may be releasably
coupled together. For example, the proximal sheath 68 can be
coupled to the distal sheath 74 using an interference fit, a
friction fit, a spline fitting, end to end butt fit or any other
type of suitable coupling between the two sheaths 68, 74. When
coupled together, the components move as a unit. For example, the
proximal sheath 68, the proximal shaft 70, the proximal filter 64,
the distal shaft 72, and the distal filter 62 will rotate and
translate axially (in the proximal or distal direction) as a unit.
When proximal sheath 68 is retracted to allow proximal filter 64 to
expand, the distal sheath 74 can be independently rotated, steered,
or translated axially (either in the proximal direction or distal
direction). The distal sheath 74 therefore has 3 independent
degrees of freedom: axial translation, rotation, and steering. The
adaptation to have 3 independent degrees of freedom is advantageous
when positioning the distal sheath 74 in a target location, details
of which are described below.
[0108] The system 60 is advanced into the subject's right radial
artery through an incision in the right arm, or alternately through
the right brachial artery. For example, the system 60 may be
advanced through the same incision as the first system 30. The
system is advanced through the right subclavian artery 22 and into
the brachiocephalic or innominate artery 12, and a portion of the
system is positioned within aortic arch 10. The proximal sheath 68
is retracted proximally to allow proximal filter support element 65
to expand to an expanded configuration against the wall of the
innominate artery 12, as is shown in FIG. 1B. The proximal filter
element 67 is secured either directly or indirectly to support
element 65 and is therefore reconfigured to the configuration shown
in FIG. 1B. The position of distal sheath 74 can be substantially
maintained while proximal sheath 68 is retracted proximally. Once
expanded, the proximal filter assembly 64 filters blood traveling
through the innominate artery 12, and therefore filters blood
traveling into the right common carotid artery 18 and the right
vertebral artery 20. The expanded proximal filter assembly 64 is
therefore in position to prevent foreign particles from traveling
into the right common carotid artery 18 and the right vertebral
artery 20 and into the cerebral vasculature.
[0109] The distal sheath 74 is then steered, or bent, and the
distal end 84 of the distal sheath 74 is advanced into the left
common carotid artery 14. The guiding member 76 is thereafter
advanced distally relative to distal sheath 74, allowing the distal
support element 61 to expand from a collapsed configuration to a
deployed configuration against the wall of the left common carotid
artery 14, as shown in FIG. 1B. The distal filter element 63 is
also reconfigured into the configuration shown in FIG. 1B. Once
expanded, the distal filter assembly 62 filters blood traveling
through the left common carotid artery 14. In some embodiments, the
distal filter assembly 62 may be deployed prior to the deployment
of the proximal filter assembly 64. The distal filter assembly 62
is therefore in position to trap foreign particles and prevent them
from traveling into the cerebral vasculature. As can be seen in
FIG. 1B, together the first protection system 30 and the second
protection system 60 collectively trap foreign particles and
prevent them from traveling into the four arteries 14, 18, 20, 24
that carry oxygenated blood to the brain.
[0110] The filter system(s) 30, 60 can thereafter be removed from
the subject (or at any point in the procedure). In an exemplary
embodiment, distal filter assembly 62 is first retrieved back
within distal sheath 74 to the collapsed configuration. To do this,
the guiding member 76 is retracted proximally relative to the
distal sheath 74. This relative axial movement causes the distal
sheath 74 to engage a strut or wire 86 and begin to move strut 86
towards guiding member 76. The support element 61, which is coupled
to the strut 86, begins to collapse upon the collapse of the strut
86. The filter element 63 therefore begins to collapse as well.
Continued relative axial movement between the guiding member 76 and
the distal sheath 74 continues to collapse the strut 86, the
support element 61, and the filter element 63 until the distal
filter assembly 62 is retrieved and re-collapsed back within distal
sheath 74 (not explicitly shown). Any foreign particles trapped
within the distal filter element 63 are contained therein as the
distal filter assembly 62 is re-sheathed. The distal sheath 74 is
then steered into a configuration where the distal sheath 74 is
generally parallel with the distal shaft 72. Said differently, the
distal sheath 74 is steered such that it has generally linear
orientation. The proximal sheath 70 is then advanced distally
relative to proximal filter assembly 64. This causes proximal
filter assembly 64 to collapse around distal shaft 72, trapping any
particles within the collapsed proximal filter 67. The proximal
sheath 68 continues to be moved distally towards the distal sheath
74 until the proximal sheath 68 is coupled with or nearly coupled
with the distal sheath 74. The entire system 60 can then be removed
from the subject.
[0111] Once the second filter system 60 has been removed from the
body, the outer sheath 42 of the first filter system 30 can be
advanced (e.g., over a guidewire 56 or the filter wire 52b) such
that the filter assembly 32 may be retracted back into the outer
sheath 42 (e.g., by distally advancing the outer sheath 42 and/or
by proximally retracting the filter assembly 32). The action to
re-sheathe the filter assembly 32 may by opposite to the action to
unsheathe the filter assembly 32 (e.g., retraction of a slider and
advancement of the slider, respectively) or may be a completely
different action. The inner member 50 may be distally advanced
before, during, or after re-sheathing of the filter assembly 32.
Radiopaque markers, for example on the filter assembly 32 can help
determine when the filter assembly 32 achieves a compressed state.
Differential longitudinal movement of the filter assembly 32 and
the outer sheath 42 can cease upon full or appropriate capture of
the filter assembly 32. Radiopaque fluid may be provided through
the inner member 50. Embolic material trapped in the filter
assembly 32 may also be captured by the re-sheathing process. Once
the protection device 30 is in a compressed state, the protection
device 30 may be proximally retracted out of the right subclavian
artery 22.
[0112] In any of the embodiments mentioned herein, the filter or
filter assemblies 32, 62, 64 may alternatively be detached from the
delivery catheter, and the delivery catheter removed leaving the
filter 32, 62, 64 behind. The filter or filter assemblies 32, 62,
64 can be left in place permanently, or retrieved by snaring it
with a retrieval catheter following a post procedure treatment
period of time. Alternatively, the filter assemblies 32, 62, 64 may
remain attached to the catheter, and the catheter may be left in
place post procedure for the treatment period of time. That
treatment period may be at least one day, one week, three weeks,
five weeks or more, depending upon the clinical circumstances.
Patients with an indwelling filter or filter assemblies may be
administered any of a variety of thrombolytic or anticoagulant
therapies, including tissue plasminogen activator, streptokinase,
coumadin, heparin and others known in the art.
[0113] FIG. 1C illustrates an alternative embodiment for the
systems of FIGS. 1A and 1B. In FIG. 1B, the filter wire 52b remains
within the body (e.g., within the vasculature) but remains outside
of the second filter system 60. In the embodiment of FIG. 1C, the
first filter system 30 may be deployed as discussed above. The
second filter system 60 may then be advanced over the filter wire
52b of the first filter system 30 via a port 90 in the distal
sheath 74. The filter wire 52b is contained within a lumen of the
second filter system 60 for a length less than an entirety of the
length of the second first system 60 rather than running along and
outside of the second filter system 60. The second filter system 60
may then be deployed as discussed above.
[0114] FIGS. 1D and 1E illustrate another alternative embodiment
for the systems of FIGS. 1A and 1B. In the embodiment of FIG. 1D,
the distal shaft 72 may include a rapid exchange port 92 which is
illustrated in more detail in FIG. 1E. The rapid exchange port 92
may allow the filter wire 52b to distally exit second filter system
proximal to the proximal filter assembly 64. A second port (not
explicitly shown) may be formed in the second filter system 60 at a
location distal to the rapid exchange port 92 to allow the filter
wire 52b to enter the second filter system 60. In some cases, the
filter wire 52b may enter then the second filter system through a
port 90 in the distal sheath 74, although this is not required. It
is contemplated that the filter wire 52b may enter through a port
formed in any of the components of the second filter system 60 or
through a distal opening of any of the components of the second
filter system 60, as desired. It is further contemplate that the
rapid exchange port 92 may be port formed in any of the components
of the second filter system 60, as desired. For example, as the
second filter system 60 is advanced into the vasculature, the
proximal end of the filter wire 52b may inserted into the port 90
(or other suitable opening). The rapid exchange port 92 may include
features that direct the proximal end of the filter wire 52b out of
the rapid exchange port 92 as the second filter system 60 is
distally advanced over the filter wire 52b. As can be seen in FIG.
1E, the filter wire 52b may deflected into and out of the rapid
exchange port 92. It should be understood that the distal shaft 72
may include other components within the lumen 73 thereof; however,
for clarity, these components are not illustrated.
[0115] FIG. 2A illustrates another illustrative protection device,
or filter system, 100 in which three filters are delivered with a
single delivery device. The filter system 100 may be similar to the
second filter system 60 described above. The filter system 100 may
include a distal end region 102 including at least a first filter
assembly 104, a second filter assembly 106, and a third filter
assembly 108 and a proximal end region (not explicitly shown)
coupled to a handle (not explicitly shown) configured to remain
outside the body. The first filter assembly 104, second filter
assembly 106, and third filter assembly 108 may each include a
support member or frame 114, 116, 118 and a filter element 120,
122, 124. The support members 114, 116, 118 may be similar in form
and function to the support member 31 described herein. The filter
elements 120, 122, 124 may be similar in form and function to the
filter element 33 described herein. In some cases, the handle of
the filter system 100 may be similar in form and function to the
handle 38 described herein. The distal end region 102 may include a
proximal sheath 110, a proximal shaft (not explicitly shown)
coupled to an expandable proximal, or third, filter assembly 108, a
distal shaft 132 (see, FIG. 2B) coupled to a distal articulatable
sheath 112, an intermediate, or second, filter assembly 106, a
distal, or first filter assembly 104, and guiding member (not
explicitly shown). As can be seen, the filter system 100 may be
structurally similar to the second filter system 100 described
herein and may be similarly arranged. However, in the filter system
100 illustrated in FIG. 2A, both the first filter assembly 104 and
the second filter assembly 106 may be loaded into the distal sheath
112 for delivery. The first and second filter assemblies 104, 106
may be coupled together via a wire or tether 126. In some cases,
the tether 126 may be made having a predetermined shape to better
assist the tether 126 in seating and spanning the distance from the
ostium of the left subclavian artery 16 to the left common carotid
artery 14.
[0116] The system 100 is advanced into the subject's right radial
artery through an incision in the right arm, or alternatively
through the right brachial artery. While not explicitly shown, the
system 100 may be advanced over or in conjunction with one or more
guidewires. The system is advanced through the right subclavian
artery 22 and into the innominate artery 12, and a portion of the
system is positioned within aortic arch 10. The proximal sheath 110
is retracted proximally to allow proximal filter support element
118 to expand to an expanded configuration against the wall of the
innominate artery 12, as is shown in FIG. 2A. The proximal filter
element 124 is secured either directly or indirectly to support
element 118 and is therefore reconfigured to the configuration
shown in FIG. 2A. The position of distal sheath 112 can be
substantially maintained while proximal sheath is retracted
proximally. Once expanded, the proximal filter assembly 108 filters
blood traveling through the innominate artery 12, and therefore
filters blood traveling into the right common carotid artery 18 and
the right vertebral artery 20. The expanded proximal filter
assembly 108 is therefore in position to prevent foreign particles
from traveling into the right common carotid artery 18 and the
right vertebral artery 20 and into the cerebral vasculature.
[0117] The distal sheath 112 is then steered, or bent, and the
distal end of the distal sheath 112 is advanced into the left
subclavian artery 16. The guiding member (not explicitly shown) is
thereafter advanced distally relative to distal sheath 112,
allowing the distal support element 114 to expand from a collapsed
configuration to a deployed configuration against the wall of the
left subclavian artery 16, as shown in FIG. 2A. Alternatively, or
additionally, the distal sheath 112 may be proximally retracted to
deploy the distal filter assembly 104. The distal filter element
120 is also reconfigured into the configuration shown in FIG. 2A.
Once expanded, the distal filter assembly 104 filters blood
traveling through the left subclavian artery 16. The expanded
distal filter assembly 104 is therefore in positioned to prevent
foreign particles from traveling into the left subclavian artery 16
and the left vertebral artery 24 and into the cerebral
vasculature
[0118] Once the distal filter assembly 104 has been positioned in
the left subclavian artery, the tether 126 may be distally advanced
to provide additional length or "slack" to allow the distal sheath
112 to be repositioned. The distal sheath 112 may be manipulated to
then cannulate the left common carotid artery 14. The guiding
member (not explicitly shown) is thereafter advanced distally
relative to distal sheath 112, allowing the intermediate support
element 116 to expand from a collapsed configuration to a deployed
configuration against the wall of the left common carotid artery
14, as shown in FIG. 2A. The intermediate filter element 122 is
also reconfigured into the configuration shown in FIG. 2A. Once
expanded, the intermediate filter assembly 106 filters blood
traveling through the left common carotid artery 14. In some
embodiments, the distal filter assembly 104 and the intermediate
filter assembly 106 may be deployed prior to the deployment of the
proximal filter assembly 108. The intermediate filter assembly 106
is therefore in position to trap foreign particles and prevent them
from traveling into the cerebral vasculature. As can be seen in
FIG. 2A, the protection system 100 traps foreign particles and
prevent them from traveling into the four arteries 14, 18, 20, 24
that carry oxygenated blood to the brain. It is contemplated that
when the procedure is completed, the insertion steps may be
performed in reverse to remove the system 100.
[0119] FIGS. 2B and 2C illustrate an alternative embodiment of the
illustrative protection device, or filter system, 100 of FIG. 2A in
which three filters are delivered with a single delivery device. In
the embodiment of FIGS. 2B and 2C, the first and second filter
assemblies 104, 106 each include their own filter wire 128, 130.
For example, the first and second filter assemblies 104, 106 may be
free from the tether 126 illustrated in FIG. 2A. The embodiment of
FIGS. 2B and 2C may be deployed in a similar manner to the
embodiment of FIG. 2A.
[0120] The system 100 is advanced into the subject's right radial
artery through an incision in the right arm. The system is advanced
through the right subclavian artery 22 and into the innominate
artery 12, and a portion of the system is positioned within aortic
arch 10. The proximal sheath 110 is retracted proximally to allow
proximal filter support element 118 to expand to an expanded
configuration against the wall of the innominate artery 12, as is
shown in FIG. 2B. The proximal filter element 124 is secured either
directly or indirectly to support element 118 and is therefore
reconfigured to the configuration shown in FIG. 2B. The position of
distal sheath 112 can be substantially maintained while proximal
sheath is retracted proximally. Once expanded, the proximal filter
assembly 108 filters blood traveling through the innominate artery
12, and therefore filters blood traveling into the right common
carotid artery 18 and the right vertebral artery 20. The expanded
proximal filter assembly 108 is therefore in position to prevent
foreign particles from traveling into the right common carotid
artery 18 and the right vertebral artery 20 and into the cerebral
vasculature.
[0121] The distal sheath 112 is then steered, or bent, and the
distal end of the distal sheath 112 is advanced into the left
subclavian artery 16. The guiding member (not explicitly shown) is
thereafter advanced distally relative to distal sheath 112,
allowing the distal support element 114 to expand from a collapsed
configuration to a deployed configuration against the wall of the
left subclavian artery 16, as shown in FIG. 2B. Alternatively, or
additionally, the distal sheath 112 may be proximally retracted to
deploy the distal filter assembly 104. The distal filter element
120 is also reconfigured into the configuration shown in FIG. 2A.
Once expanded, the distal filter assembly 104 filters blood
traveling through the left subclavian artery 16. The expanded
distal filter assembly 104 is therefore in positioned to prevent
foreign particles from traveling into the left subclavian artery 16
and the left vertebral artery 24 and into the cerebral
vasculature
[0122] Once the distal filter assembly 104 has been positioned in
the left subclavian artery, the distal sheath 112 may be
manipulated to then cannulate the left common carotid artery 14.
The guiding member (not explicitly shown) is thereafter advanced
distally relative to distal sheath 112, allowing the intermediate
support element 116 to expand from a collapsed configuration to a
deployed configuration against the wall of the left common carotid
artery 14, as shown in FIG. 2C. The intermediate filter element 122
is also reconfigured into the configuration shown in FIG. 2C. Once
expanded, the intermediate filter assembly 106 filters blood
traveling through the left common carotid artery 14. In some
embodiments, the distal filter assembly 104 and the intermediate
filter assembly 106 may be deployed prior to the deployment of the
proximal filter assembly 108. The intermediate filter assembly 106
is therefore in position to trap foreign particles and prevent them
from traveling into the cerebral vasculature. As can be seen in
FIG. 2C, the protection system 100 traps foreign particles and
prevent them from traveling into the four arteries 14, 18, 20, 24
that carry oxygenated blood to the brain.
[0123] FIGS. 3A-3C illustrate another illustrative protection
device, or filter system, 200 in which three filters are delivered
with a single delivery device. The filter system 200 may be similar
to the second filter system 60 described above. The filter system
200 may include a distal end region 202 including at least a first
filter assembly 204 (see, for example, FIG. 3C), a second filter
assembly 206, and a third filter assembly 208 (see, for example,
FIGS. 3B and 3C and a proximal end region (not explicitly shown)
coupled to a handle (not explicitly shown) configured to remain
outside the body. The first filter assembly 204, second filter
assembly 206, and third filter assembly 208 may each include a
support member or frame 214, 216, 218 and a filter element 220,
222, 224 (see, for example, FIG. 3C). The support members 214, 216,
218 may be similar in form and function to the support member 31
described herein. The filter elements 220, 222, 224 may be similar
in form and function to the filter element 33 described herein. In
some cases, the handle of the filter system 200 may be similar in
form and function to the handle 38 described herein. The distal end
region 202 may include a proximal sheath 210, a proximal shaft (not
explicitly shown) coupled to an expandable proximal, or third,
filter assembly 208, a distal shaft 226 coupled to a distal
articulatable sheath 212, an intermediate, or second, filter
assembly 206, a distal, or first filter assembly 204, and guiding
member (not explicitly shown). As can be seen, the filter system
200 may be structurally similar to the second filter system 200
described herein and may be similarly arranged. However, in the
filter system 200 illustrated in FIG. 3A, both the second filter
assembly 206 and the third filter assembly 208 may be loaded into
the proximal sheath 210 for delivery. The second and third filter
assemblies 206, 208 may be coupled together via a flexible link
228. In some cases, the flexible link 228 may be made having a
predetermined shape to better assist the second filter assembly 206
in cannulation of the left common carotid artery 14. It is
contemplated that in some instances, the flexible link 228 may be
formed as a dual wire system.
[0124] The system 200 is advanced into the subject's right radial
artery through an incision in the right arm, or alternatively
through the right brachial artery. While not explicitly shown, the
system 200 may be advanced over or in conjunction with one or more
guidewires. The system is advanced through the right subclavian
artery 22 and into the innominate artery 12, and both the distal
sheath 212 and a distal portion of the of proximal sheath 210
positioned within the ascending portion of the aorta 10.
[0125] The proximal sheath 210 is retracted proximally to allow
intermediate filter support element 216 to expand to an expanded
configuration within the aorta 10. The system 200 may then be
retracted (e.g., proximally displaced) to move the intermediate
filter assembly 206 into the left common carotid artery 14, as
shown at arrow 230. The predetermined hook shape of the flexible
link 228 may help guide the intermediate filter assembly 206 into
place. The intermediate support element 216 is moved against the
wall of the left common carotid artery 14, as shown in FIG. 3B. The
intermediate filter element 222 is also reconfigured into the
configuration shown in FIG. 3B. Once expanded, the intermediate
filter assembly 206 filters blood traveling through the left common
carotid artery 14. In some embodiments, the distal filter assembly
204 and the intermediate filter assembly 206 may be deployed prior
to the deployment of the proximal filter assembly 208. The
intermediate filter assembly 206 is therefore in position to trap
foreign particles and prevent them from traveling into the cerebral
vasculature
[0126] The proximal sheath 210 then be further proximally
retracted, as shown at arrow 232, to deploy the proximal filter
assembly 208. The position of distal sheath 212 can be
substantially maintained while proximal sheath 210 is retracted
proximally. The proximal sheath 210 is retracted proximally to
allow proximal filter support element 218 to expand to an expanded
configuration against the wall of the innominate artery 12, as is
shown in FIG. 3B, with the flexible link 228 spanning the distance
between the ostium of the left common carotid artery 14 and the
innominate artery 12. In some cases, the shape and/or curvature of
the flexible link 228 may be manipulated by varying the distance
the proximal sheath 210 is retracted. The proximal filter element
224 is secured either directly or indirectly to support element 218
and is therefore reconfigured to the configuration shown in FIG.
3B. Once expanded, the proximal filter assembly 208 filters blood
traveling through the innominate artery 12, and therefore filters
blood traveling into the right common carotid artery 18 and the
right vertebral artery 20. The expanded proximal filter assembly
208 is therefore in position to prevent foreign particles from
traveling into the right common carotid artery 18 and the right
vertebral artery 20 and into the cerebral vasculature.
[0127] The distal sheath 212 is then steered, or bent, and the
distal end of the distal sheath 212 is advanced into the left
subclavian artery 16. The guiding member (not explicitly shown) is
thereafter advanced distally relative to distal sheath 212,
allowing the distal support element 214 to expand from a collapsed
configuration to a deployed configuration against the wall of the
left subclavian artery 16, as shown in FIG. 3C. Alternatively, or
additionally, the distal sheath 212 may be proximally retracted to
deploy the distal filter assembly 204. The distal filter element
220 is also reconfigured into the configuration shown in FIG. 3C.
Once expanded, the distal filter assembly 204 filters blood
traveling through the left subclavian artery 16. The expanded
distal filter assembly 204 is therefore in positioned to prevent
foreign particles from traveling into the left subclavian artery 16
and the left vertebral artery 24 and into the cerebral vasculature.
As can be seen in FIG. 3C, the protection system 200 traps foreign
particles and prevent them from traveling into the four arteries
14, 18, 20, 24 that carry oxygenated blood to the brain. It is
contemplated that when the procedure is completed, the insertion
steps may be performed in reverse to remove the system 200.
[0128] FIGS. 4A-4C illustrate another illustrative protection
device, or filter system, 300 in which three filters are delivered
separately. The filter system 300 may include steerable sheath 310,
a first filter assembly 304, a second filter assembly 306 (see, for
example, FIG. 4B, and a third filter assembly 308 (see, for
example, FIG. 4C), and a proximal end region (not explicitly shown)
coupled to a handle (not explicitly shown) configured to remain
outside the body. The first filter assembly 304, second filter
assembly 306, and third filter assembly 308 may each include a
support member or frame 314, 316, 318 and a filter element 320,
322, 324 (see, for example, FIG. 3C). The support members 314, 316,
318 may be similar in form and function to the support member 31
described herein. The filter elements 320, 322, 324 may be similar
in form and function to the filter element 33 described herein. In
some cases, the handle of the filter system 300 may be similar in
form and function to the handle 38 described herein.
[0129] The steerable sheath 310 is advanced into the subject's
right radial artery through an incision in the right arm, or
alternatively through the right brachial artery. While not
explicitly shown, the system 300 may be advanced over or in
conjunction with one or more guidewires. The sheath 310 is advanced
through the right subclavian artery 22 and into the innominate
artery 12, the arch of aorta 10 to a site proximate the ostium of
the left subclavian artery 16 (if not actually cannulating left
subclavian artery 16). The first filter assembly 304 may then be
advanced through a lumen of the sheath 310. Alternately, the first
filter assembly 304 may be pre-loaded within the sheath 310 and
advanced therewith. The filter assembly 304 may be distally
advanced from the sheath 310 (or the sheath 310 proximally
retracted) to allow the distal filter support element 314 to expand
from a collapsed configuration to a deployed configuration against
the wall of the left subclavian artery 16, as shown in FIG. 4A. The
distal filter element 320 is also reconfigured into the
configuration shown in FIG. 4A. Once expanded, the distal filter
assembly 304 filters blood traveling through the left subclavian
artery 16. The expanded distal filter assembly 304 is therefore in
positioned to prevent foreign particles from traveling into the
left subclavian artery 16 and the left vertebral artery 24 and into
the cerebral vasculature.
[0130] After placement of the first filter assembly 304, the sheath
310 completely withdrawn from the patient such that the filter wire
330 (similar in form and function to filter wire 52b described
herein) is free from the sheath 310. The steerable sheath 310 is
then advanced into the subject's right radial artery through the
incision in the right arm. The sheath 310 is advanced through the
right subclavian artery 22 and into the innominate artery 12, the
arch of aorta 10 to a site proximate the ostium of the left common
carotid artery 14 (if not actually cannulating left common carotid
artery 30). The second filter assembly 306 may then be advanced
through a lumen of the sheath 310. Alternately, the second filter
assembly 306 may be pre-loaded within the sheath 310 and advanced
therewith. The filter assembly 306 may be distally advanced from
the sheath 310 (or the sheath 310 proximally retracted) to allow
the intermediate filter support element 316 to expand from a
collapsed configuration to a deployed configuration against the
wall of the left common carotid artery 14, as shown in FIG. 4B. The
intermediate filter element 322 is also reconfigured into the
configuration shown in FIG. 4B. Once expanded, the intermediate
filter assembly 306 filters blood traveling through the left common
carotid artery 14. The intermediate filter assembly 306 is
therefore in position to trap foreign particles and prevent them
from traveling into the cerebral vasculature.
[0131] After placement of the second filter assembly 306, the
sheath 310 is again completely withdrawn from the patient such that
a second filter wire 332 (similar in form and function to filter
wire 52b described herein) is free from the sheath 310. The
steerable sheath 310 is then advanced into the subject's right
radial artery through the incision in the right arm. The sheath 310
is advanced through the right subclavian artery 22 and into the
innominate artery 12. The third filter assembly 308 may then be
advanced through a lumen of the sheath 310. Alternately, the third
filter assembly 308 may be pre-loaded within the sheath 310 and
advanced therewith. The filter assembly 308 may be distally
advanced from the sheath 310 (or the sheath 310 proximally
retracted) to allow the proximal filter support element 318 to
expand from a collapsed configuration to a deployed configuration
against the wall of the innominate artery 12, as shown in FIG. 4C.
The proximal filter element 324 is also reconfigured into the
configuration shown in FIG. 4C and filters blood traveling through
the innominate artery 12, and therefore filters blood traveling
into the right common carotid artery 18 and the right vertebral
artery 20. The expanded proximal filter assembly 308 is therefore
in position to prevent foreign particles from traveling into the
right common carotid artery 18 and the right vertebral artery 20
and into the cerebral vasculature. After placement of the third
filter assembly 308, the sheath 310 is again completely withdrawn
from the patient such that a third filter wire (not explicitly
shown) (similar in form and function to filter wire 52b described
herein) is free from the sheath 310. As can be seen in FIG. 4C, the
protection system 300 traps foreign particles and prevent them from
traveling into the four arteries 14, 18, 20, 24 that carry
oxygenated blood to the brain. It is contemplated that when the
procedure is completed, the insertion steps may be performed in
reverse to remove the system 300.
[0132] FIG. 5 illustrates another illustrative protection device,
or filter system 400 in which two filters may be utilized to
protect all four arteries 14, 18, 20, 24 that carry oxygenated
blood to the brain. The filter system 400 may include an inner
sheath 402, an outer sheath 404, a first, or distal, filter
assembly 406, a second, or proximal, filter assembly 408, and a
proximal end region (not explicitly shown) coupled to a handle (not
explicitly shown) configured to remain outside the body. In some
embodiments, one or both of the inner sheath 402 and the outer
sheath 404 may be steerable. The first filter assembly 406 and the
second filter assembly 408 may each include a support member or
frame 410, 412 and a filter element 414, 416. The support members
410, 412 may be similar in form and function to the support member
31 described herein. The filter elements 414, 416 may be similar in
form and function to the filter element 33 described herein. The
second filter assembly 408 may be configured to over the ostium of
the both the innominate artery 12 and the left common carotid
artery 14. In some cases, the handle of the filter system 400 may
be similar in form and function to the handle 38 described
herein.
[0133] The filter system 400 may be advanced into the subject's
right radial (or alternatively, the right brachial) artery through
an incision in the right arm. While not explicitly shown, the
system 400 may be advanced over or in conjunction with one or more
guidewires. The system 400 is advanced through the right subclavian
artery 22 and into the innominate artery 12 until the distal end
418 of the outer sheath 404 is adjacent to the ostium 420 of the
innominate artery 12. The outer sheath 404 may then be proximally
retracted to deploy the proximal filter assembly 408 over the ostia
420, 422 of the innominate and left common carotid arteries 12, 14.
As can be seen, the support member 412 and the filter element 416
of the proximal filter assembly 408 may be sized and shaped to
extend over both the ostia 420, 422 of the innominate and left
common carotid arteries 12, 14. The inner sheath 402 may then be
distally advanced toward and, sometimes through, the ostium 424 of
the left subclavian artery 16. The inner sheath 402 may be
proximally retracted to deploy the distal filter assembly 406
within the left subclavian artery 16. Alternatively, the order in
which the filter assemblies 406, 408 are deployed may be reversed.
It is contemplated that when the procedure is completed, the
insertion steps may be performed in reverse to remove the system
500.
[0134] FIG. 6A illustrates another illustrative protection device,
or filter system 500 in which a deflector 504, a distal filter
assembly 506, and a proximal filter assembly 508 may be utilized to
protect all four arteries 14, 18, 20, 24 that carry oxygenated
blood to the brain. The filter system 500 may similar in form and
function to the filter system 100 described above. The filter
system 500 may include a distal end region 502 including at least a
deflector 504, a distal filter assembly 506, and a proximal filter
assembly 508 and a proximal end region (not explicitly shown)
coupled to a handle (not explicitly shown) configured to remain
outside the body. The deflector 504, distal filter assembly 506,
and proximal filter assembly 508 may each include a support member
or frame 514, 516, 518 and a filter element 520, 522, 524. The
support members 514, 516, 518 may be similar in form and function
to the support member 31 described herein. The filter elements 520,
522, 524 may be similar in form and function to the filter element
33 described herein. However, the deflector 504 may have a
generally planar shape such that foreign particulates are not
necessarily trapped within the filter element 520 as the deflector
is removed. However, the structure of the deflector 504 may be such
that blood flow removed any foreign particulates away from the
ostium of the left subclavian artery 16 to reduce the likelihood of
a foreign particulate entering the left vertebral artery 24. In
some cases, the handle of the filter system 500 may be similar in
form and function to the handle 38 described herein.
[0135] The distal end region 502 may include a proximal sheath 510,
a proximal shaft (not explicitly shown) coupled to an expandable
proximal filter assembly 508, a distal shaft (not explicitly shown)
coupled to a distal articulatable sheath 512, a proximal filter
assembly 506, a deflector 504, and guiding member (not explicitly
shown). As can be seen, the filter system 500 may be structurally
similar to the second filter system 60 and/or the filter system 100
described herein and may be similarly arranged. However, in the
filter system 500 illustrated in FIG. 6A, both the deflector 504
and the distal filter assembly 506 may be loaded into the distal
sheath 512 for delivery. The deflector and the distal filter
assembly 504, 506 may be coupled together via a wire or tether 526.
In some cases, the tether 526 may be made have a predetermined
shape to better assist the tether 526 in seating and spanning the
distance from the ostium of the left subclavian artery 16 to the
left common carotid artery 14.
[0136] The system 500 is advanced into the subject's right radial
artery through an incision in the right arm, or alternatively
through the right brachial artery. While not explicitly shown, the
system 500 may be advanced over or in conjunction with one or more
guidewires. The system is advanced through the right subclavian
artery 22 and into the innominate artery 12, and a portion of the
system is positioned within aortic arch 10. The proximal sheath 510
is retracted proximally to allow proximal filter support element
518 to expand to an expanded configuration against the wall of the
innominate artery 12, as is shown in FIG. 6A. The proximal filter
element 524 is secured either directly or indirectly to support
element 518 and is therefore reconfigured to the configuration
shown in FIG. 6A. The position of distal sheath 512 can be
substantially maintained while proximal sheath is retracted
proximally. Once expanded, the proximal filter assembly 508 filters
blood traveling through the innominate artery 12, and therefore
filters blood traveling into the right common carotid artery 18 and
the right vertebral artery 20. The expanded proximal filter
assembly 508 is therefore in position to prevent foreign particles
from traveling into the right common carotid artery 18 and the
right vertebral artery 20 and into the cerebral vasculature.
[0137] The distal sheath 512 is then steered, or bent, and the
distal end of the distal sheath 512 is advanced into the left
common carotid artery 14. The guiding member (not explicitly shown)
is thereafter advanced distally relative to distal sheath 512,
allowing the deflector 504 and the distal filter assembly 506 to be
discharged from the distal end of the distal sheath 512. The
pre-formed tether 526 may position the deflector proximate the
ostium of the left subclavian artery 16 while the distal filter
assembly 506 is positioned in the left common carotid artery 14. As
the distal filter assembly is deployed, the distal support element
516 expands from a collapsed configuration to a deployed
configuration against the wall of the left common carotid artery
14, as shown in FIG. 6A. The distal filter element 522 is also
reconfigured into the configuration shown in FIG. 6A. Once
expanded, the distal filter assembly 506 filters blood traveling
through the left common carotid artery 14. Similarly, the deflector
support element 514 expands from a collapsed configuration to a
deployed configuration against the wall of the left subclavian
artery 16, as shown in FIG. 6A. The deflector filter element 520 is
also reconfigured into the configuration shown in FIG. 6A. Once
expanded, the deflector 504 filters blood traveling through the
left subclavian artery 16. The distal filter assembly 506 is
therefore in position to trap foreign particles and prevent them
from traveling into the cerebral vasculature and the expanded
deflector 504 is in positioned to prevent foreign particles from
traveling into the left subclavian artery 16 and the left vertebral
artery 24 and into the cerebral vasculature.
[0138] It is contemplated that the deflector 504 may not be coupled
or linked to the distal filter assembly 506 via the tether 526
(e.g., the tether 526 is not present in the system 500). In such an
instance, the deflector 504 may include a deflector wire 528a,
528b. It is contemplated that the deflector is provided with only a
single wire 528a or 528b. However, the deflector wire 528a may be
positioned outside of the distal sheath 512 (and in some cases,
also outside of the proximal sheath 510). In other embodiments, the
deflector wire 528b may be disposed within a lumen of the distal
sheath 512 and/or the proximal sheath 510.
[0139] In some embodiments, the deflector 504 and the distal filter
assembly 506 may be deployed prior to the deployment of the
proximal filter assembly 508. It is contemplated that when the
procedure is completed, the insertion steps may be performed in
reverse to remove the system 500. As can be seen in FIG. 6A, the
protection system 500 traps foreign particles and prevent them from
traveling into the four arteries 14, 18, 20, 24 that carry
oxygenated blood to the brain.
[0140] FIG. 6B illustrates an alternative embodiment of the
illustrative protection system 500 of FIG. 6A where the distal
filter assembly 506 has been replaced with a spring-loaded filter
assembly 540. The spring-loaded filter assembly 540 may include a
spring-loaded expandable frame 542 and a filter element 544. The
spring-loaded expandable frame 542 may have a resiliency or
compressibility that allows the spring-loaded filter assembly 540
to be deployed within the aorta 10 and subsequently guided into the
left common carotid artery 14. The filter element 544 may be
similar in form and function to the filter element 33 described
herein.
[0141] In the embodiment of FIG. 6B, the system 500 is advanced
into the subject's right radial artery through an incision in the
right arm, or alternatively through the right brachial artery.
While not explicitly shown, the system 500 may be advanced over or
in conjunction with one or more guidewires. The system is advanced
through the right subclavian artery 22 and into the innominate
artery 12, and a portion of the system may positioned within aortic
arch 10. The deflector 504 and the spring-loaded filter assembly
540 may be distally advanced from the distal end of the distal
sheath 512 in the aorta 10. The articulable distal sheath 512 may
then be manipulated to cannulate the left common carotid artery 14
thereby deploying the spring-loaded filter assembly 540 in the left
common carotid artery 14 and the deflector 504 across the left
subclavian artery 16. The proximal sheath 510 may then be retracted
to deploy the proximal filter assembly 508. As can be seen in FIG.
6A, the protection system 500 traps foreign particles and prevent
them from traveling into the four arteries 14, 18, 20, 24 that
carry oxygenated blood to the brain. It is contemplated that when
the procedure is completed, the insertion steps may be performed in
reverse to remove the system 500.
[0142] FIG. 7A illustrates another illustrative protection device
600, or filter system in which a single, oversized filter assembly
604 covers the ostia of the left subclavian, left common carotid
and innominate arteries 16, 14, 12, which conforming to the curve
of the aortic arch 10. Referring additionally to FIG. 7B, which
illustrates a schematic view of the filter assembly 604 outside of
the body, the filter assembly 604 may include an expandable frame
606 (which may be similar in form and function to the support
member 31 described herein), a porous filter material 608 (which
may be similar in form and function to the filter element 33
described herein), one or more deployment wires 610, 612 and one or
more pull wires 614, 616. The deployment wires 610, 612 may be
actuated to exert a force on the frame 606 to shift or bias the
filter assembly 604 off axis (shown at arrow 618). The deployment
wires 610, 612 may be configured to extend through a lumen of a
delivery sheath 602 to a point outside the body where the
deployment wires 610, 612 can be manipulated by a user. The pull
wires 614, 616 may be actuated to exert a force on the frame 606 to
help conform the frame 606 to the upper curve of the aortic arch 10
((shown at arrow 620). In this manner, not only are all cerebral
arteries 14, 18, 20, 24 protected but the filter assembly 604 may
not interfere with medical devices, catheters, etc., being passed
through the aortic arch 10.
[0143] The system 600 is advanced into the subject's right radial
artery through an incision in the right arm, or alternatively
through the right brachial artery. While not explicitly shown, the
system 600 may be advanced over or in conjunction with one or more
guidewires. The system is advanced through the right subclavian
artery 22 and into the innominate artery 12, and a portion of the
system may positioned within aortic arch 10. The filter assembly
604 may be distally advanced from the distal end of the guide
sheath 602 and partially into the aorta 10. The deployment wires
610, 612 and/or the pull wires 614, 616 may then be manipulated to
position the filter assembly 604 in the desired orientation, such
that the filter assembly 604 covers the ostia of the left
subclavian, left common carotid and innominate arteries 16, 14, 12.
The guide sheath 602 may then be retracted or left within the
vasculature during the remainder of the procedure. As can be seen
in FIG. 7A, the protection system 600 traps (and/or deflects)
foreign particles and prevents them from traveling into the four
arteries 14, 18, 20, 24 that carry oxygenated blood to the brain.
It is contemplated that when the procedure is completed, the
insertion steps may be performed in reverse to remove the system
6
[0144] FIG. 7C illustrates another illustrative protection device
700, or filter system in which a single, oversized filter assembly
704 covers the ostia of the left subclavian, left common carotid
and innominate arteries 16, 14, 12, which conforming to the curve
of the aortic arch 10. The filter assembly 704 may include an
expandable frame 706 (which may be similar in form and function to
the support member 31 described herein) and a porous filter
material 708 (which may be similar in form and function to the
filter element 33 described herein). The filter material 708 may
include a first shaped section 710, a second shaped section 712,
and a third shaped sections 714 configured to prolapse into the
left subclavian, left common carotid, and innominate arteries 16,
14, 12, respectively. FIG. 7D illustrates a magnified view of the
second shaped section 712. While FIG. 7D is described with respect
to the second shaped section 712, the first and third shaped
sections 710, 714 may be similarly formed. In some embodiments, the
shaped section 712 can be laser drilled, creating holes allowing
blood 716 to pass while filtering debris. In some cases, the hole
spacing can be denser at the top 718a of the shaped section 712 and
become less dense as it nears the end 718b adjacent to the ostia.
However, this is not required. When so provided, the denser holes
at the top 718a of the shaped section 712 can cause an increased
resistance to blood flow in the area of the shaped section nearer
the ostia 718b and, conversely, decreased resistance to blood flow
out of the shaped sections 718a where increased flow is needed. The
areas, near the ostia, 718b where resistance to flow is increased
may create better wall apposition thus reducing risk of debris
passing between the membrane 708 and the ostia of the left
subclavian, left common carotid and innominate arteries 16, 14, 12.
This selective resistance to blood flow may create effective
sealing without comprising filtering.
[0145] The system 700 is advanced into the subject's right radial
artery through an incision in the right arm, or alternatively
through the right brachial artery. While not explicitly shown, the
system 700 may be advanced over or in conjunction with one or more
guidewires. The system is advanced through the right subclavian
artery 22 and into the innominate artery 12, and a portion of the
system may positioned within aortic arch 10. The filter assembly
704 may be distally advanced from the distal end of the guide
sheath 702 and partially into the aorta 10. The filter assembly 704
may be manipulated such that it covers the ostia of the left
subclavian, left common carotid and innominate arteries 16, 14, 12.
In some cases, the filter assembly 704 may include deployment wires
and/or pull wires similar to those described with respect to FIGS.
7A and 7B to facilitate placement of the filter assembly 704. The
guide sheath 702 may then be retracted or left within the
vasculature during the remainder of the procedure. As can be seen
in FIG. 7A, the protection system 700 traps (and/or deflects)
foreign particles and prevents them from traveling into the four
arteries 14, 18, 20, 24 that carry oxygenated blood to the brain.
It is contemplated that when the procedure is completed, the
insertion steps may be performed in reverse to remove the system
700.
[0146] While the methods and devices described herein may be
susceptible to various modifications and alternative forms,
specific examples thereof have been shown in the drawings and are
described in detail herein. It should be understood, however, that
the inventive subject matter is not to be limited to the particular
forms or methods disclosed, but, to the contrary, covers all
modifications, equivalents, and alternatives falling within the
spirit and scope of the various implementations described and the
appended claims. Further, the disclosure herein of any particular
feature, aspect, method, property, characteristic, quality,
attribute, element, or the like in connection with an
implementation or embodiment can be used in all other
implementations or embodiments set forth herein. In any methods
disclosed herein, the acts or operations can be performed in any
suitable sequence and are not necessarily limited to any particular
disclosed sequence and not be performed in the order recited.
Various operations can be described as multiple discrete operations
in turn, in a manner that can be helpful in understanding certain
embodiments; however, the order of description should not be
construed to imply that these operations are order dependent.
Additionally, the structures described herein can be embodied as
integrated components or as separate components. For purposes of
comparing various embodiments, certain aspects and advantages of
these embodiments are described. Not necessarily all such aspects
or advantages are achieved by any particular embodiment. Thus, for
example, embodiments can be carried out in a manner that achieves
or optimizes one advantage or group of advantages without
necessarily achieving other advantages or groups of advantages. The
methods disclosed herein may include certain actions taken by a
practitioner; however, the methods can also include any third-party
instruction of those actions, either expressly or by implication.
For example, actions such as "deploying a self-expanding filter"
include "instructing deployment of a self-expanding filter." The
ranges disclosed herein also encompass any and all overlap,
sub-ranges, and combinations thereof. Language such as "up to," "at
least," "greater than," "less than," "between," and the like
includes the number recited. Numbers preceded by a term such as
"about" or "approximately" include the recited numbers and should
be interpreted based on the circumstances (e.g., as accurate as
reasonably possible under the circumstances, for example .+-.5%,
.+-.10%, .+-.15%, etc.). For example, "about 7 mm" includes "7 mm."
Phrases preceded by a term such as "substantially" include the
recited phrase and should be interpreted based on the circumstances
(e.g., as much as reasonably possible under the circumstances). For
example, "substantially straight" includes "straight."
[0147] Those skilled in the art will recognize that the present
invention may be manifested in a variety of forms other than the
specific embodiments described and contemplated herein.
Accordingly, departure in form and detail may be made without
departing from the scope and spirit of the present invention as
described in the appended claims.
* * * * *